The Recall Desk

Manufacturer

GE Medical Systems, LLC

113 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.

101–113 of 113

  • 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-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-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-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-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-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-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-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-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
  • 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