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.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal pa
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal pa
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patie
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patie
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
December 5, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patie
Hazard: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Panda Wall Mount warmer. Infant radiant warmer
Hazard: Potential electric leakage affecting the user.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestand
Hazard: Potential electric leakage affecting the user.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded
Hazard: Potential electric leakage affecting the user.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radian
Hazard: Potential electric leakage affecting the user.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Cares
Hazard: Potential electric leakage affecting the user.
November 28, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestat
Hazard: Potential electric leakage affecting the user.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSC
Hazard: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISY
Hazard: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10
Hazard: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Millennium MC
Hazard: A detector can detach and fall.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Hazard: A detector can detach and fall.
November 21, 2018Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Hazard: A detector can detach and fall.
November 14, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from v
Hazard: Synchronization failure
November 14, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammog
Hazard: Synchronization failure
October 24, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Hazard: Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls CT Goldseal BrightSpeed 16 PWR TIO 2 YR
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Optima CT 540
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Optima CT 520
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls CT Goldseal Optima CT 600
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT 160 1.5D STD WAUK
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Discovery RT labeled as: a. MID BJG; b. HVY BJG
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
August 8, 2018Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MI Digital Ready
Hazard: DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).