GE Healthcare
48 federal recalls on file, showing the 29 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for GE Healthcare and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-15FDA-DrugClass IICheck Omnipaque injection lot numbers immediately
GE Healthcare discovered particles in certain vials of Omnipaque (iohexol), a contrast dye used during medical imaging procedures. The contamination affects 11 specific lot numbers distributed nationwide. No injuries have been reported so far.
- 2026-04-15FDA-DrugClass IICheck GE Healthcare Omnipaque injection lot numbers
GE Healthcare has recalled specific lots of Omnipaque (iohexol) injection, a contrast dye used in medical imaging, because some vials may contain visible particles. This could affect the safety of the procedure if the contaminated solution is used.
- 2026-04-08FDA-DeviceClass IICheck your GE SIGNA Premier MRI scanner
GE Healthcare SIGNA Premier whole-body MRI scanners may have steel fittings instead of brass fittings on the magnet rear. During service work while the magnet is powered up, the magnetic field could pull on these steel parts, risking injury to technicians.
- 2026-03-11FDA-DeviceClass IIContact GE Healthcare about Centricity Viewer update
GE Healthcare has identified a software issue in certain versions of its Centricity Universal Viewer Zero Footprint Client where patient information displayed in the viewer may not match the medical images being shown. This could occur in specific workflows on systems with Patient Timeline installed. The issue affects approximately 250 units.
- 2026-01-28FDA-DeviceClass IICheck your GE Omni Legend PET scanner
Certain GE Healthcare Omni Legend PET scanners may occasionally produce streaking artifacts in scan images. This visual distortion appears as lines in the images displayed on the scanner console and could affect image quality used for clinical diagnosis.
- 2026-01-21FDA-DeviceClass IICheck GE MAXXUS imaging system detector support
GE HealthCare identified that certain older GE MAXXUS Nuclear Medicine systems may have been moved or transported without proper detector support. This could damage the detector mounting and potentially cause the detector to fall, which poses a serious injury risk. No injuries or detector falls have been reported so far.
- 2026-01-21FDA-DeviceClass IICheck GE HealthCare nuclear medicine system detector support
GE HealthCare identified that certain older SMV BodyTrack nuclear medicine systems may have been moved or transported without proper detector support during their service life. This can weaken the detector mounting mechanisms. If the detector becomes loose or falls, it could cause serious injury. No injuries or detector falls have been reported so far.
- 2026-01-21FDA-DeviceClass IICheck GE HealthCare nuclear medicine system detector support
GE HealthCare discovered that certain older SMV DSI nuclear medicine systems may have been moved or transported without proper detector support. This can stress the detector mounting and potentially cause the detector to fall, which could injure someone. No falls or injuries have occurred yet.
- 2026-01-21FDA-DeviceClass IICheck GE HealthCare nuclear medicine system support
GE HealthCare identified that certain older SMV DSX nuclear medicine systems may not have been properly supported during transport or relocation. This could damage the detector mounting mechanisms and potentially cause the detector to fall, creating a serious safety risk. No injuries have been reported so far.
- 2025-12-24FDA-DeviceClass IIUpdate GE HealthCare ViewPoint 6 software
GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.
- 2025-11-19FDA-DeviceClass IIBATTERY 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.
- 2025-11-19FDA-DeviceClass IIPortrait 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.
- 2025-11-19FDA-DeviceClass IIB105P, 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 M
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.
- 2025-11-19FDA-DeviceClass IICARESCAPE 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.
- 2025-11-19FDA-DeviceClass IICarescape 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.
- 2025-10-29FDA-DeviceClass IIStarcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IISopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIOptima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIMillenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIMillenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIMillenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIMillenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIMaxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
- 2025-10-29FDA-DeviceClass IIElscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
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