The Recall Desk

Manufacturer

GE Healthcare, LLC

105 recalls in our database name GE Healthcare, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 105

  • HighFDA (Devices)·Z-1566-2022·2022-08-31

    GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

    GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

    Product
    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1511-2022·2022-08-17

    GE Healthcare CT, PET, and NM Patient Tables May Drop During Service

    GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.

    Product
    Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2022·2022-08-03

    GE Centricity PACS Software fails to notify of exam study modifications

    GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.

    Product
    Centricity PACS Software Version 7.0 SP0.0.4.7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1389-2022·2022-07-27

    GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal

    GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.

    Product
    GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2022·2022-07-27

    SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard

    GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.

    Product
    SIGNA Premier magnetic resonance scanner, model 5748519.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2022·2022-07-27

    GE Anesthesia Systems Base Cracking and Fall Hazard Recalled

    GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.

    Product
    GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1333-2022·2022-07-13

    GE Centricity Medical Imaging Software Displays Inaccurate Measurements

    GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.

    Product
    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2022·2022-07-06

    Backup batteries in Avance CS2 anesthesia machines fail prematurely

    GE Healthcare is recalling backup batteries in Avance CS2 and CS2 Pro anesthesia machines manufactured after April 1, 2019. Batteries may fail earlier than expected, affecting approximately 6,600 devices worldwide.

    Product
    Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2022·2022-07-06

    Anesthesia device backup batteries may fail prematurely, GE Healthcare recalls

    GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.

    Product
    Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2022·2022-06-22

    GE CARESCAPE Central Station power supply failure recall

    GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.

    Product
    CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1226-2022·2022-06-15

    GE Healthcare Ventilators Recalled for Insufficient Battery Backup Power

    GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.

    Product
    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1227-2022·2022-06-15

    Ventilator Backup Battery Failure Recalled by GE Healthcare Worldwide

    GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.

    Product
    Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2022·2022-06-15

    Medical imaging software distance and area measurements may display inaccurately

    Centricity Enterprise Web medical imaging software may display inaccurate distance and area measurements when processing magnified or scaled images. The software is distributed to healthcare facilities worldwide.

    Product
    Centricity Enterprise Web
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2022·2022-06-15

    Centricity Cardiology CA1000 may display inaccurate distance and area measurements

    GE Healthcare is recalling the Centricity Cardiology CA1000 software due to potential inaccurate distance and area measurements on magnified or scaled-down images, which could affect diagnostic accuracy.

    Product
    Centricity Cardiology CA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2022·2022-06-15

    Medical imaging software may display inaccurate measurement values

    GE Healthcare's Centricity Universal Viewer Zero Footprint Client may display inaccurate distance and area measurements on magnified or scaled images.

    Product
    Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2022·2022-04-27

    GE Healthcare MRI Systems May Fall During De-Installation Without Proper Rigging

    GE Healthcare MRI systems may fall during magnet de-installation if rigging and hardware are not properly installed and secured, creating a potential injury hazard.

    Product
    GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2022·2022-04-20

    MUSE Cardiology System edits and diagnosis data lost after test signed

    GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.

    Product
    MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0857-2022·2022-04-13

    Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal

    GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.

    Product
    Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2022·2022-04-13

    GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images

    GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.

    Product
    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2022·2022-04-13

    GE Healthcare MRI Systems May Display Flipped Images Affecting Diagnosis

    GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.

    Product
    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2022·2022-04-13

    CT Scanner Dose Display Error in GE Healthcare Revolution Systems

    GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.

    Product
    Revolution Apex, Revolution CT with Apex Edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2022·2022-04-13

    CT Scanner Dose Display Shows Inaccurate Values in Certain Situations

    GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.

    Product
    Revolution CT, Revolution CT ES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2022·2022-04-13

    GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip

    GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.

    Product
    SIGNA Excite 3T. Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide