GE Healthcare Recalls
567 recalls on record · June 27, 2012 to April 8, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 20, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergenc
Hazard: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
February 6, 2013Medical DevicesFDA
GE Healthcare, LLC recalls AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Hazard: It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
January 2, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1
Hazard: Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
December 26, 2012Medical DevicesFDA
GE Healthcare, LLC recalls Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and versio
Hazard: GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety. 2) A refresh problem of the stenosis / aneurysm measurement tools associated with the cardio-vascular applications of
December 26, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/
Hazard: GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
December 26, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supe
Hazard: GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.
December 5, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Op
Hazard: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
December 5, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx,
Hazard: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
December 5, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx,
Hazard: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
November 28, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Hazard: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
November 28, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Hazard: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
November 28, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
Hazard: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
November 28, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and
Hazard: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review statio
Hazard: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained
Hazard: GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopi
Hazard: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic
Hazard: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic
Hazard: It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
October 31, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage
Hazard: GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
September 19, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ)
Hazard: GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
September 19, 2012Medical DevicesFDA
GE Healthcare, LLC recalls Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Hazard: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
September 19, 2012Medical DevicesFDA
GE Healthcare, LLC recalls Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Hazard: Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
August 22, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) pr
Hazard: GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
July 25, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995
Hazard: GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
July 25, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures
Hazard: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
July 18, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Ver
Hazard: GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
June 27, 2012Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Hazard: GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m