GE Healthcare Recalls
567 recalls on record · June 27, 2012 to April 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 14, 2015Medical DevicesFDA
GE Healthcare recalls Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammog
Hazard: Images may be missing when a system parameter MapRoute is set to a value greater than 1.
September 30, 2015Medical DevicesFDA
GE Healthcare recalls PET Discovery ST 16
Hazard: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
September 30, 2015Medical DevicesFDA
GE Healthcare recalls PET Discovery LS
Hazard: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
September 30, 2015Medical DevicesFDA
GE Healthcare recalls Lightspeed 16 CT
Hazard: Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
September 2, 2015Medical DevicesFDA
GE Healthcare recalls Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archivi
Hazard: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
September 2, 2015Medical DevicesFDA
GE Healthcare recalls Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture ar
Hazard: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
August 12, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinit
Hazard: A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
July 29, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Precision MPi fluoroscopic imaging systems.
Hazard: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
July 29, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Precision RXi Digital system
Hazard: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
July 29, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Precision RXi 23A/32A Analog System
Hazard: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
July 29, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Precision 500D Classical R & F system.
Hazard: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of huma
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of huma
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of huma
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of huma
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoros
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Hazard: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
July 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnosti
Hazard: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
July 1, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise te
Hazard: GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
June 3, 2015Medical DevicesFDA
GE Healthcare recalls D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) an
Hazard: A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a loss of respiratory airway gas monitoring.
May 27, 2015Medical DevicesFDA
GE Healthcare recalls CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner ut
Hazard: GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res
May 20, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Hazard: The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment
May 13, 2015Medical DevicesFDA
GE Healthcare recalls GE Discovery MR950 MRI system
Hazard: The alignment lasers are missing the labels required by radiation safety regulations.