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.
July 6, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Hazard: Backup batteries can fail earlier than their estimated life.
June 22, 2022Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU an
Hazard: The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Centricity PACS RA1000
Hazard: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Cardiology CA1000
Hazard: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Radiology RA600
Hazard: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Enterprise Web
Hazard: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer Zero Footprint Client
Hazard: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst
Hazard: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
June 15, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)
Hazard: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
April 27, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery
Hazard: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
April 20, 2022Medical DevicesFDA
GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Hazard: Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Hazard: There is potential for the images to be flipped left to right.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Excite 3T. Magnetic Resonance Imaging System
Hazard: There is potential for the images to be flipped left to right.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Hazard: There is potential for the images to be flipped left to right.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Hazard: There is potential for the images to be flipped left to right.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT, Revolution CT ES
Hazard: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
April 13, 2022Medical DevicesFDA
GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition
Hazard: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
March 23, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082
Hazard: If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnet
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imag
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imagin
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance im
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
February 16, 2022Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic
Hazard: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.