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GE Healthcare LLC FDA Recalls
110 recalls on file across devices, 3 of them Class I and 83 still open. Matched by name to GEHC.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| SIGNA Premier systemsClass IIFeb 27, 2026Whole-Body MR scanners used to produce images of the inside |
| (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3Class IIJul 15, 2022Inaccurate Distance and Area measurements with use of Global |
| SIGNA Premier magnetic resonance scanner, model 5748519.Class IIJun 24, 2022Under rare conditions, SIGNA Premier gradient coils could re |
| Centricity PACS Software Version 7.0 SP0.0.4.7Class IIJun 14, 2022The Event Notification Manager (ENM) functionality for certa |
| GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data withClass IIJun 8, 2022Potential to display inaccurate measurements on images in Ce |
| Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High CapClass IIJun 2, 2022As a result of unclear guidance in the service manual, the t |
| GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia SysteClass IJun 1, 2022There is a potential reversal of the O2 and air cylinder pre |
| GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, PartClass IIMay 27, 2022The base of the anesthesia system can have a crack and could |
| CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU anClass IIMay 10, 2022The CARESAPE Central Station (CSCS) V2 can shut down due to |
| Centricity PACS RA1000Class IIApr 28, 2022Potential for Distance and Area measurements to display inac |
| Centricity Radiology RA600Class IIApr 28, 2022Potential for Distance and Area measurements to display inac |
| Centricity Cardiology CA1000Class IIApr 28, 2022Potential for Distance and Area measurements to display inac |
| Centricity Enterprise WebClass IIApr 28, 2022Potential for Distance and Area measurements to display inac |
| Centricity Universal Viewer Zero Footprint ClientClass IIApr 28, 2022Potential for Distance and Area measurements to display inac |
| Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, AmingoClass IIApr 25, 2022Backup batteries can fail earlier than their estimated life. |
| Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019Class IIApr 25, 2022Backup batteries can fail earlier than their estimated life. |
| Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)Class IApr 18, 2022Insufficient battery backup power resulting in premature shu |
| Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and EngstClass IApr 18, 2022Insufficient battery backup power resulting in premature shu |
| MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008Class IIMar 16, 2022Two scenarios may cause edits to measurements and diagnosis |
| GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery Class IIMar 4, 2022During the de-installation of an MR system magnet, if all ri |
| Signa 1.5T TwinSpeed Magnetic Resonance Imaging SystemClass IIFeb 18, 2022There is potential for the images to be flipped left to righ |
| 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging SystemClass IIFeb 18, 2022There is potential for the images to be flipped left to righ |
| SIGNA Excite 3T. Magnetic Resonance Imaging SystemClass IIFeb 18, 2022There is potential for the images to be flipped left to righ |
| 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging SystemClass IIFeb 18, 2022There is potential for the images to be flipped left to righ |
| GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082Class IIJan 28, 2022If the CARESCAPE Central Station v2.0 is used with an unappr |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonancClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imagingClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR SysteClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonanceClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition sClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonanceClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magneClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA HorizonClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imagClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance syClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonanceClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic reClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaginClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magneticClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonaClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclearClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance iClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combiningClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nucClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magneticClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resClass IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance Class IIDec 23, 2021The magnetic resonance systems could potentially have a cryo |
| GE Vscan Extend, being sold as "Vscan Extend Sector USB"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Console"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Dual USB"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"Class IINov 4, 2021The firm identified that the Vscan Extend device will not po |
| GE Centricity Universal Viewer Zero Footprint ClientClass IIOct 15, 2021There is a potential to display incomplete patient imaging s |
| SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| SIGNA Premier nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| SIGNA Voyager nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| SIGNA Pioneer nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| Discovery MR750 3.0T nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| Optima MR450w 1.5T nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| SIGNA Architect nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| Discovery MR750w 3.0T nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| SIGNA Artist nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging systemClass IIAug 26, 2021Under certain conditions, some slices may be missing which c |
| Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing systemClass IIAug 12, 2021A software anomaly exists in the Centricity Universal Viewer |
| Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograClass IIAug 6, 2021Image acquisition failures and synchronization failure with |
| Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammogramsClass IIAug 6, 2021Image acquisition failures and synchronization failure with |
| Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOClass IIAug 2, 2021The flow sensors built prior to June 2021 could have damaged |
| Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (Class IIAug 2, 2021The flow sensors built prior to June 2021 could have damaged |
| The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission daClass IIJun 30, 2021When adding one or more intended scan groups names must cont |
| The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission prClass IIJun 30, 2021When adding one or more intended scan groups names must cont |
| The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission prClass IIJun 30, 2021When adding one or more intended scan groups names must cont |
| Revolution Apex, Revolution CT with Apex EditionClass IIJun 30, 2021The accumulated dose is incorrectly displayed in certain sit |
| Revolution CT, Revolution CT ESClass IIJun 30, 2021The accumulated dose is incorrectly displayed in certain sit |
| Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionClass IIJun 30, 2021The accumulated dose is incorrectly displayed in certain sit |
| AMX Navigate Mobile X-Ray SystemClass IIJun 24, 2021An unexpected column motion while attempting to park the col |
| Revolution EVO, Optima CT660, Optima CT680 CT Systems.Class IIJun 14, 2021Improperly loaded software options may result in additional |
| SIGNA Artist, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA MR380, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA Voyager, Nuclear Magnetic Resonance Imaging SystemClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high siClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hiClass IIJun 4, 2021GE Healthcare has recently become aware of an issue on the a |
| CARESCAPE PDM-Masimo SpO2. Physiological data monitor.Class IIMay 21, 2021Masimo SpO2 Saturation Values can become frozen after an ext |
| Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG applicaClass IIApr 19, 2021If a certain sequence of events occur, the pdf test report t |
| GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614)Class IIApr 19, 2021The IGS system can experience a single vertical line defect |
| Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, anClass IIMar 19, 2021When the Cross Enterprise Display option is enabled on the C |
| Revolution CTClass IIMar 19, 2021GE Healthcare has become aware of a potential issue on the R |
| NM/CT 870 DR Nuclear Medicine / CT ScannersClass IIFeb 7, 2021GE Healthcare has become aware of a potential issue on 800 f |
| NM/CT 850 Nuclear Medicine / CT ScannersClass IIFeb 7, 2021GE Healthcare has become aware of a potential issue on 800 f |
| NM/CT 860 Nuclear Medicine / CT ScannersClass IIFeb 7, 2021GE Healthcare has become aware of a potential issue on 800 f |