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.

101–125 of 168

  • HighFDA (Devices)·Z-2460-2024·2024-08-14

    GE SIGNA Pioneer MR Systems May Overheat Patient Implants During Scanning

    GE SIGNA Pioneer MR systems with certain software versions may allow radiofrequency exposure to exceed prescribed limits in Low SAR Mode when using specific imaging sequences, potentially causing overheating of MR conditional implants.

    Product
    SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2477-2024·2024-08-14

    GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk

    GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.

    Product
    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2479-2024·2024-08-14

    GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

    GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

    Product
    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2462-2024·2024-08-14

    GE SIGNA Premier MRI system software overheating risk to implants

    GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.

    Product
    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2473-2024·2024-08-14

    MR System Software Defect May Cause Implant Overheating During Scanning

    GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.

    Product
    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2481-2024·2024-08-14

    SIGNA UHP MRI System Software Versions May Cause Implant Overheating

    GE Medical Systems is recalling SIGNA UHP MRI systems with software versions RX28.0 or MR30.1. A configuration issue can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants.

    Product
    SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2484-2024·2024-08-14

    SIGNA MAGNUS MRI Software Can Overheat Implanted Devices

    GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.

    Product
    SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2469-2024·2024-08-14

    GE SIGNA Artist MR system may overheat implants in certain sequences

    GE Medical Systems is recalling SIGNA Artist MR imaging systems because they may produce radiofrequency power exceeding user-set limits when using certain imaging sequences in Low SAR Mode, potentially causing MR-conditional implants to overheat.

    Product
    SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2482-2024·2024-08-14

    MRI System Software Error Can Cause Implant Overheating in Low SAR Mode

    GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.

    Product
    Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0733-2023·2022-12-28

    GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Altitude

    GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.

    Product
    B125M Patient Monitor, REF 6160000-005-XXXXXXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0759-2023·2022-12-28

    Ultrasound System Batteries May Fail, Emit Smoke, or Catch Fire

    GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.

    Product
    Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skelet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2023·2022-12-28

    Vivid i N ultrasound device batteries may fail, smoke, or catch fire

    GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.

    Product
    Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2023·2022-12-28

    GE B125M Patient Monitor CO2 Measurement Inaccuracy at High Elevations

    GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.

    Product
    B125M Patient Monitor, REF 6160000-004-XXXXXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0755-2023·2022-12-28

    GE Vivid S6 N Ultrasound Battery Fire Risk Recall

    GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.

    Product
    Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2023·2022-12-28

    Medical Imaging Software Update May Hide Patient Studies

    After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2023·2022-12-28

    GE Vivid S6 Ultrasound Systems Recalled for Battery Fire Risk

    GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.

    Product
    Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2023·2022-12-28

    Vivid S5 N Ultrasound Systems Recalled for Potential Battery Fire Hazard

    GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.

    Product
    Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2023·2022-12-28

    GE Vivid S5 Ultrasound Systems Battery Failure Fire Risk

    GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.

    Product
    Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2023·2022-12-28

    GE Vivid i Ultrasound Systems Battery Failure Recall

    GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.

    Product
    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cepha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2023·2022-12-28

    GE Centricity Universal Viewer 6.0 Medical Imaging Software May Hide Studies

    GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.

    Product
    Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2023·2022-12-28

    GE Vivid q Ultrasound Systems: Battery Fire Risk Recall

    GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.

    Product
    Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superfi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2023·2022-12-28

    GE B105M Patient Monitor displays inaccurate CO2 readings at altitude

    GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.

    Product
    B105M Patient Monitor, REF 6160000-003
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0729-2023·2022-12-28

    GE Patient Monitors May Display Inaccurate CO2 Readings at Non-Sea-Level Locations

    GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.

    Product
    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0236-2019·2018-10-31

    GE Medical Systems Recalls Signa Architect MRI Scanners Due to Burn Risk

    GE Medical Systems is recalling four Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause a serious burn if proper padding is not used.

    Product
    SIGNA Architect system Product Usage: The Signa Architect 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

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.