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.
February 26, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems
Hazard: GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
February 12, 2014Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a profes
Hazard: There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M12264
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road La
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part **
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare recalls Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www
Hazard: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
February 12, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray Syste
Hazard: GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
February 5, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter pati
Hazard: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.
February 5, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiograp
Hazard: GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring
February 5, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of th
Hazard: There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen
January 29, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninte
Hazard: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
January 29, 2014Medical DevicesFDA
GE Healthcare, LLC recalls SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product
Hazard: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
January 29, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiolog
Hazard: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
January 29, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Leg
Hazard: Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.
January 22, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acqui
Hazard: GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
January 22, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555
Hazard: There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w
January 15, 2014Medical DevicesFDA
GE Healthcare, LLC recalls SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Hazard: GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
December 25, 2013Medical DevicesFDA
GE Healthcare, LLC recalls Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Fi
Hazard: GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
December 18, 2013Medical DevicesFDA
GE Healthcare, LLC recalls HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor
Hazard: GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The
November 27, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for c
Hazard: GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.
November 27, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 syste
Hazard: GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a
November 20, 2013Medical DevicesFDA
GE Healthcare, LLC recalls AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server.
Hazard: GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tom
Hazard: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmis
Hazard: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended
Hazard: GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system t
Hazard: GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventila
Hazard: GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
October 23, 2013Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Hazard: GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv