← Every firm
Philips Medical Systems Nederland B.V. FDA Recalls
209 recalls on file across devices, 20 of them Class I and 209 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software VersiClass IIJul 16, 2026Two software related issues: 1) Potential image quality de |
| Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, Class IIJul 16, 2026Two software related issues affecting Azurion R2.2.10 System |
| Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluorosClass IIJun 29, 2026Firmware issue potentially leading to loss of geometry movem |
| Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model NumClass IIJun 17, 2026Potential Loss of imaging functionality, loss of motorized m |
| Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model NumbeClass IIJun 17, 2026Potential Loss of imaging functionality, loss of motorized m |
| Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.Class IIJun 17, 2026Potential Loss of imaging functionality, loss of motorized m |
| Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034Class IIMay 18, 2026Philips Allura Xper and MultiDiagnost-Eleva systems Hand sw |
| Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura XpClass IIMay 18, 2026Philips Allura Xper and MultiDiagnost-Eleva systems Hand sw |
| Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),Class IIApr 30, 2026It was identified that HDDs used in the PCs of Azurion and A |
| Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR TClass IIApr 30, 2026It was identified that HDDs used in the PCs of Azurion and A |
| Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), IntegClass IIApr 28, 2026The deaeration hose in X-ray tube cooling units type CU3101, |
| Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura XClass IIApr 28, 2026The deaeration hose in X-ray tube cooling units type CU3101, |
| Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions anClass IIApr 28, 2026Potential safety issue with Philips Azurion systems, where l |
| Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (Class IIApr 28, 2026The deaeration hose in X-ray tube cooling units type CU3101, |
| Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),Class IIMar 31, 2026Potential for the bolts and plastic parts of the Cable Hose |
| Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intendedClass IIMar 19, 2026Potential safety issue involving the Mean Aneurysm Flow Ampl |
| Vue Motion V12. Product Number: 1017979.Class IIMar 5, 2026Potential that mis-ordered frames in Vue Motion during dynam |
| ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD20/20; System Code: 722038;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD10C; System Code: 722001;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD20/15 OR Table; System Code: 722059;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD10F; System Code: 722002;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD20/15; System Code: 722058;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD20/20 OR Table; System Code: 722039;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Allura Xper FD20/10; System Code: 722029;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 5 M12; System Code: (1)722227, (2)722231;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;Class IIMar 3, 2026Philips has identified instances where X-ray imaging may not |
| Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, RClass IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -Class IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.XClass IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - AlClass IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.Class IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:Class IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, Class IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.Class IIJan 26, 2026Under certain conditions, the table may move unexpectedly wh |
| Allura Xper FD20; Model Number: 722006;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10; Model Number: 722026;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20; Model Number: 722028;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20 Biplane; Model Number: 722008;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Product Name: Allura Xper FD10C; Model number: 722001;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10F; Model Number: 722002;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10/10; Model Number: 722027;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20/20; Model Number: 722038;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10/10; Model Number: 722011;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10/10; Model Number: 722005;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20 Biplane; Model Number: 722013;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10; Model Number: 722010;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20; Model Number: 722012;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD10; Model Number: 722003;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20/10; Model Number: 722029;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Allura Xper FD20 OR Table; Model Number: 722023;Class IIDec 15, 2025Philips has identified that in a limited number of impacted |
| Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresClass IIDec 12, 2025Six (6) identified software issues which may result in the f |
| Philips Azurion system; Software Version Number: R3.1;Class IIDec 12, 2025Philips has identified two (2) software issues affecting dev |
| Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. MClass IIDec 8, 2025Nine (9) identified software issues which may result in the |
| Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;Class IIOct 2, 2025The motorized longitudinal movement of the FlexArm stand may |
| Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray systemClass IISep 29, 2025Over time some systems may experience loss of imaging functi |
| Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842,Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979Class IISep 3, 2025The BIOS battery may deplete faster than initially anticipat |
| Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638,Class IISep 3, 2025Systems may not perform as intended due to the deterioration |
| IntelliSpace Cardiovascular, Software 8.0.0.4.Class IIAug 8, 2025Software issue that results in the display of outdated infor |
| Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding modelClass IIAug 1, 2025Potential that a component (air baffle) may be missing in so |
| Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with correspClass IIAug 1, 2025Philips Azurion and Allura systems configured with a 1 Phas |
| Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with correClass IIAug 1, 2025Philips Azurion and Allura systems configured with a 1 Phas |
| Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura XperClass IIJun 30, 2025Potential for temporary loss of imaging (X-ray) functionalit |
| Azurion 7 M20. Fluoroscopic X-Ray System.Class IIJun 4, 2025Potential for bolts connecting the gearbox to the mounting f |
| Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (Class IIMay 28, 2025A software issue was identified in the internal communicatio |
| IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.Class IIApr 7, 2025An issue was identified with the software when using the Ech |
| Intera 1.0T Omni/Stellar, Model Number: 781102;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T Master/Nova, Model Number: 781106;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 3.0T Quasar Dual, Model Number: 781150;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T Explorer/Nova Dual, Model Number: 781108;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T R11, Model Number: 781170;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T Omni/Stellar, Model Number: 781104;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.0T Power/Pulsar, Model Number: 781103;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera CV, Model Number: 781107;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 0.5T Standard, Model Number: 781101;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| SmartPath to dStream for 3.0T, Model Number: 782145;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| SmartPath to dStream for 1.5T, Model Number: 782146;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Enterprise 1.5T, Model Number: 781145;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T Power/Pulsar, Model Number: 781105;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T, Model Numbers: 781195 and 781295;Class IIMar 24, 2025The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;Class IIFeb 28, 2025Multiple problems identified with the software version leadi |
| Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD20/20 System Code: (1) 722038Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD10C System Code: (1) 722001Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 3 M12 System Code: (1) 722063 (2) 722221Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| AlluraXperFD20/15 System Code: (1) 722058Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura CV20 System Code: 722031Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD20/15; Catalog numbers: 722058Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);Class IJan 13, 2025Possibility of the patient falling from the table related to |
| AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD20/10; Catalog numbers: 722029Class IJan 13, 2025Possibility of the patient falling from the table related to |
| AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura CV20; Catalog numbers: 722031Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD20/20; Catalog numbers: 722038Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Allura Xper FD10C; Catalog number: 722001Class IJan 13, 2025Possibility of the patient falling from the table related to |
| AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| AlluraXperFD20/10 System Code: (1) 722029Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,Class IJan 13, 2025Possibility of the patient falling from the table related to |
| Azurion 5 M12 System Code: (1) 722227 (2) 722231Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025Class IIJan 13, 2025Potential safety issue with the AD7 and AD7X patient tables |
| Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Class IINov 11, 2024Potential safety issues in Allura Xper R7.6- R8.1 systems wh |
| Philips Zenition 70, Model Number: 718133Class IIOct 7, 2024Potential for the Mains Control Unit board fuse may blow out |
| Philips Zenition 50, Model Number: 718096Class IIOct 7, 2024Potential for the Mains Control Unit board fuse may blow out |
| System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 MClass IIAug 22, 2024Potential Detachment of the Cable Hose Carrier (due to broke |
| System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS AllurClass IIAug 22, 2024Potential Detachment of the Cable Hose Carrier (due to broke |
| System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 AClass IIAug 22, 2024Potential Detachment of the Cable Hose Carrier (due to broke |
| System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiaClass IIAug 22, 2024Potential Detachment of the Cable Hose Carrier (due to broke |
| Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722Class IIAug 8, 2024A half-threaded bolt was included in the LTE kits instead of |
| Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model NumberClass IIAug 6, 2024The motorized longitudinal movement of the FlexArm stand may |
| Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for IClass IIJul 15, 2024Potential Loss of Imaging (X-ray) Functionality and/or Longe |
| Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.Class IIMay 16, 2024When Software upgrade 8.1.100 is installed on an Allura Xper |
| Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1Class IIMay 16, 2024When Software upgrade 8.1.100 is installed on an Allura Xper |
| Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.Class IIMay 16, 2024When Software upgrade 8.1.100 is installed on an Allura Xper |
| Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of Class IIMay 2, 2024Potential for pressure wave data synchronization from two de |
| Philips IntelliSpace Cardiovascular software, Model 830089.Class IIApr 4, 2024Study data is not able to be archived, copied, or exported w |
| Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgClass IIFeb 6, 2024Generator may fail due to a potential short circuit in the P |
| Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgClass IIFeb 6, 2024Generator may fail due to a potential short circuit in the P |
| Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surClass IIFeb 6, 2024Generator may fail due to a potential short circuit in the P |
| Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affectedClass IIJan 2, 2024Framegrabber card may not perform as intended. Monitor may s |
| Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affectedClass IIJan 2, 2024Disk Bay may not perform as intended. System may stop functi |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) usedClass IIJan 2, 2024Dual In-Line Memory Modules (DIMMs) may not perform as inten |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affectedClass IIJan 2, 2024Framegrabber card may not perform as intended. Monitor may s |
| Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affectedClass IIJan 2, 2024Disk Bay may not perform as intended. System may stop functi |
| Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7Class IIDec 12, 2023System may exhibit a loss of imaging functionality and data |
| Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)Class IIDec 8, 2023Loss of connectivity between the FlexArm and the Table due t |
| Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)Class IIDec 8, 2023Loss of connectivity between the FlexArm and the Table due t |
| Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 witClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 witClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the RoClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 Class IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 witClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the RoClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 withClass IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 Class IIDec 7, 2023During the device phase of Roadmap Pro, a user may experienc |
| Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 AzurionClass IINov 3, 2023Ceiling mounted L-arm contains a rotation cover that may pot |
| Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Class IINov 3, 2023Ceiling mounted L-arm contains a rotation cover that may pot |
| Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systemsClass IIAug 15, 2023A damaged foot switch may cause instances where no or only i |
| Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as wClass IIJul 20, 2023Philips has become aware of the potential for unintended rad |
| MultiDiagnost-ElevaClass IIJul 19, 2023A foot switch pedal may get stuck in the active position whe |
| Allura Xper seriesClass IIJul 19, 2023A foot switch pedal may get stuck in the active position whe |
| AzurionClass IIJul 19, 2023A foot switch pedal may get stuck in the active position whe |
| Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray SystemsClass IIJun 30, 2023Loss of availability of the wireless foot switch during proc |
| Azurion 7 M20. X-ray Image guided Therapy System.Class IIJun 12, 2023The bolts supporting the FlexMove Carriage may become loose |
| Allura Xper FD10 and FD20. X-ray Imaging System.Class IIJun 12, 2023The bolts supporting the FlexMove Carriage may become loose |
| Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) AClass IIMar 21, 2023Potential Loss of X-ray-When the full disk capacity is reach |
| SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6Class IIFeb 20, 2023There are technical issues related to signal generation and |
| 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1Class IIFeb 20, 2023There are technical issues related to signal generation and |
| Veradius Unity, Model #718132Class IIDec 2, 2021Firm discovered that the wireless foot switch can suddenly s |
| Zenition 70, Model #718133Class IIDec 2, 2021Firm discovered that the wireless foot switch can suddenly s |
| Zenition 50, Model #718096Class IIDec 2, 2021Firm discovered that the wireless foot switch can suddenly s |
| Azurion systems with software release R1.xClass IIMay 26, 2021In the Azurion system, the user can add a new study to a pat |