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Getinge Usa Sales Inc FDA Recalls
48 recalls on file across devices, 9 of them Class I and 46 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, FlClass IJan 15, 2025Sevoflurane used with the vaporizer may degrade to hydrogen |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during aClass IIOct 3, 2024Error code "50037" occurs on the IR-Hand Control when a MEER |
| ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5Class IIMay 29, 2024The recall is prompted by a defective charger unit (0970.287 |
| ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4Class IIMay 29, 2024The recall is prompted by a defective charger unit (0970.287 |
| ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5Class IIMay 29, 2024The recall is prompted by a defective charger unit (0970.287 |
| Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40Class IMay 1, 2024Sevoflurane used with the vaporizer may degrade to hydrogen |
| Flow-e Anesthesia System, model 6887900Class IIDec 11, 2023Potential cybersecurity vulnerability that could lead to a D |
| Flow-i C30 Anesthesia System, model 6677300Class IIDec 11, 2023Potential cybersecurity vulnerability that could lead to a D |
| Flow-c Anesthesia System, model 6887700Class IIDec 11, 2023Potential cybersecurity vulnerability that could lead to a D |
| Flow-i C40 Anesthesia System, model 6677400Class IIDec 11, 2023Potential cybersecurity vulnerability that could lead to a D |
| Flow-i C20 Anesthesia System, model 6677200Class IIDec 11, 2023Potential cybersecurity vulnerability that could lead to a D |
| Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD5Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT3Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, XClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model NumberClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MBClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD5675Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101AClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 1Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111CClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROClass IINov 8, 2023A potential for a light system to fall in the operating room |
| Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 Class IINov 8, 2023A potential for a light system to fall in the operating room |
| Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventClass IISep 6, 2023Under certain conditions, an issue might prevent the device |
| Getinge Flow-e Anesthesia System, Part No. 6887900Class IDec 22, 2022Due to a software bug, under certain conditions, pressure ca |
| Getinge Flow-c Anesthesia System, Part No. 6887700Class IDec 22, 2022Due to a software bug, under certain conditions, pressure ca |
| Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677Class IDec 22, 2022Due to a software bug, under certain conditions, pressure ca |
| Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)Class IINov 7, 2022The power backup battery, under certain conditions, may exhi |
| Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20ANClass IIOct 14, 2022The back rest may unintentionally drop suddenly, resulting i |
| Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatmeClass IIJul 21, 2022Device does not meet regulatory requirements of stability wh |
| Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number Class IJul 20, 2022Ventilators may generate a combination of alarms which may r |
| VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP Class IIMay 6, 2022Paint particles may detach and fall in the operating field. |
| Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patClass IMay 2, 2022Potential for crack to form on the on/off switch of the suct |
| Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patiClass IMay 2, 2022Potential for crack to form on the on/off switch of the suct |
| Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfectingClass IIApr 13, 2022Verification of installation not documented or may be incomp |
| Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disClass IIApr 13, 2022Verification of installation not documented or may be incomp |
| Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.Class IIApr 1, 2022Inadequate documentation verifying whether device installati |
| Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI:Class IDec 9, 2021A potential chemical degradation of Sevoflurane by Lewis aci |