GE Healthcare
FDA adverse event reports naming GE Healthcare as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GE HEALTHCARE.
- Total reports
- 1,842
- Deaths
- 104
- Injuries
- 183
- Malfunctions
- 1,446
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX547
- Detector And Alarm, ArrhythmiaDSI262
- System, Image Processing, RadiologicalLLZ215
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT122
- Gas-Machine, AnesthesiaBSZ115
- Source, Brachytherapy, RadionuclideKXK68
- Ventilator, Continuous, Facility UseCBK55
- System, Monitoring, PerinatalHGM29
- System, X-Ray, Fluoroscopic, Image-IntensifiedJAA27
- OximeterDQA26
Recent recalls
- 2026-04-02Open, ClassifiedNonconforming Material/Component
SIGNA Premier systems
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
- 2026-02-27Open, ClassifiedDevice Design
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
- 2025-12-16Open, ClassifiedDevice Design
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
- 2025-11-07Open, ClassifiedComponent change control
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- 2025-11-07Open, ClassifiedComponent change control
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- 2025-11-07Open, ClassifiedComponent change control
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- 2025-11-07Open, ClassifiedComponent change control
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- 2025-11-07Open, ClassifiedComponent change control
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- 2025-10-21Open, ClassifiedSoftware design
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
- 2025-10-21Open, ClassifiedSoftware design
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
Monitor GE Healthcare automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.