The Recall Desk

Manufacturer

GE Medical Systems, LLC

168 recalls in our database name GE Medical Systems, LLC as the manufacturing or recalling firm.

What the numbers show

Total
168
Critical
0
Severe
4
Most recent
2026-07-22

Of the 168 recalls from GE Medical Systems, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) are Severe.

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.

126–150 of 168

  • HighFDA (Devices)·Z-0553-2016·2018-10-31

    GE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk

    GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.

    Product
    GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0201-2019·2018-10-31

    GE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk

    GE Medical Systems is recalling 356 Discovery 3.0T MR750 MRI scanners because a specific coil can overheat in Mode 2, posing a risk of serious patient thermal injury.

    Product
    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0112-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems worldwide because software issues may cause flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2019·2018-10-24

    GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled

    GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.

    Product
    GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3279-2018·2018-10-03

    GE Medical Systems Recalls Discovery MR750w MRI Systems Due to Burn Risk

    GE Medical Systems is recalling 516 Discovery MR750w MRI systems because a small area on the bore surface can become warm enough to cause a serious burn if a patient touches it without proper padding.

    Product
    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2018·2018-08-01

    GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

    GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

    Product
    MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3027-2017·2017-08-23

    GE Signa MRI Systems Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Signa MRI systems due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3024-2017·2017-08-23

    GE Optima MR450w 1.5T MRI Scanner Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Optima MR450w 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2017·2017-08-23

    GE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring

    GE Medical Systems is recalling 68 Brivo MR355 and Optima MR360 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.

    Product
    Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3022-2017·2017-08-23

    GE Medical Systems Recalls Optima MR450 1.5T Scanners for Wiring Defect

    GE Medical Systems is recalling 68 Optima MR450 1.5T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3026-2017·2017-08-23

    GE Medical Systems Recalls MRI Scanners Due to Power Supply Wiring

    GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3023-2017·2017-08-23

    GE Optima MR750 MRI Scanner Recalled for Potential Shock Hazard

    GE Medical Systems is recalling 68 Optima MR750 MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3029-2017·2017-08-23

    GE Medical Systems Recalls Signa PET/MR Systems Due to Shock Hazard

    GE Medical Systems is recalling 68 Signa PET/MR systems because possible incorrect wiring of the Uninterruptable Power Supply could contribute to a potential shock hazard.

    Product
    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3025-2017·2017-08-23

    GE Medical Systems Recalls Discovery MR750 3.0T Scanners for Shock Hazard

    GE Medical Systems is recalling 68 Discovery MR750 3.0T MRI scanners due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

    Product
    Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3028-2017·2017-08-23

    GE MRI Scanners Recalled for Potential Power Supply Shock Hazard

    GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the uninterruptible power supply, which could create a shock hazard.

    Product
    1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2016·2016-06-01

    GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss

    GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2016·2016-06-01

    GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss

    GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2016·2016-05-11

    GE Revolution CT Recalled for Potential X-Ray Tube Loosening

    GE Medical Systems is recalling 26 Revolution CT systems worldwide because a manufacturing error may cause the X-ray tube to loosen, leading to scan errors or image artifacts.

    Product
    GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1562-2016·2016-05-04

    GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect

    GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and ventilation.

    Product
    GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1381-2016·2016-04-20

    GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue

    GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.

    Product
    GE Healthcare, Aisys CS2 anesthesia..
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1382-2016·2016-04-20

    GE Healthcare Recalls Aisys Carestation Anesthesia Devices Due to Bolus Issue

    GE Healthcare is recalling Aisys Carestation anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.

    Product
    GE Healthcare, Aisys Carestation.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1347-2016·2016-04-13

    GE Medical Systems Recalls SIGNA Pioneer MR Systems Due to Ferrous Material Risk

    GE Medical Systems is recalling 16 SIGNA Pioneer MR systems because ferrous material in the Table Control Box could cause unexpected attraction to the magnetic field during servicing, posing a risk of serious injury to personnel.

    Product
    SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 522 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corre
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1051-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 324 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body att
    Category
    Medical Device
    Distribution
    4 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

GE Medical Systems Global Technology

R&D Subsidiary of GE Healthcare

Country
United States
Parent company
GE HealthCare

Source: Wikidata (Q21168536), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.