The Recall Desk

Manufacturer

GE Medical Systems, LLC

124 recalls in our database name GE Medical Systems, 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.

76–100 of 124

  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2025·2025-01-15

    Tec 850 SEV Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.

    Product
    Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2025·2025-01-15

    Tec 820 ISO Anesthesia Vaporizers can deliver less anesthetic than dial setting

    GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.

    Product
    Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2025·2025-01-15

    Anesthesia Vaporizers May Deliver Less Anesthetic Than Dial Setting Due to Manufacturing Defect

    Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.

    Product
    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2025·2024-12-04

    Discovery MR750w MRI Scanner Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling 8 Discovery MR750w 3.0T MRI scanners because their gradient coils can produce elevated acoustic noise during scanning under specific conditions.

    Product
    Discovery MR750w 3.0T, whole body magnetic resonance scanner
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2025·2024-12-04

    GE SIGNA Architect AIR MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling three SIGNA Architect AIR MRI systems due to gradient coils that can produce elevated acoustic noise during scanning. The units were distributed to the US and 12 countries worldwide.

    Product
    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2025·2024-12-04

    GE SIGNA Architect MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling certain SIGNA Architect MRI systems because their gradient coils can produce elevated acoustic noise during scanning under specific conditions, potentially risking hearing damage.

    Product
    SIGNA Architect, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2025·2024-12-04

    GE SIGNA and DISCOVERY PET/MR Scanners Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling SIGNA PET/MR and DISCOVERY PET/MR imaging systems because gradient coils can produce elevated acoustic noise during scanning under specific conditions.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2024·2024-08-14

    MRI System Software Issue Can Overheat Implanted Medical Devices

    GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

    Product
    SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2461-2024·2024-08-14

    MRI System Software Miscalculation May Overheat Patient Implants

    A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.

    Product
    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2483-2024·2024-08-14

    MRI System Software Error Can Overheat Patient Implants

    GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

    Product
    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; 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-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-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-2474-2024·2024-08-14

    SIGNA MR380 MRI system software may exceed implant heating limits

    GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.

    Product
    SIGNA MR380, with affected software versions: SV25.5, SV25.6; 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-2463-2024·2024-08-14

    GE SIGNA HDxt 3.0T MRI systems may overheat implanted devices

    GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.

    Product
    3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2459-2024·2024-08-14

    SIGNA Architect MRI System Software Can Exceed Implant Heating Limits

    GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.

    Product
    SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2476-2024·2024-08-14

    GE SIGNA MR360 MRI System Software Defect May Overheat Implants

    GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.

    Product
    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2465-2024·2024-08-14

    GE Discovery MR750w MRI System Software May Overheat Implants

    GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.

    Product
    Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states