The Recall Desk

FDA (Devices) recall action 89376

GE Healthcare, LLC recalled 32 products on 2022-02-16

The FDA (Devices) publishes a recall like this one as 32 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 32 pages.

Products
32
Announced
2022-02-16
Critical
0
Units
551,296

Why these products were recalled

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 32

  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects

    GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling Discovery MR750w 3.0T MRI systems due to cryogen ventilation systems that may not meet FDA venting requirements. Approximately 17,228 devices were affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE SIGNA MRI Systems Recalled for Cryogen Ventilation Defect

    GE Healthcare is recalling 17,228 MRI systems with a potential cryogen ventilation system defect that may not meet regulatory venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall

    GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Recalled for Cryogen Ventilation Issue

    GE Healthcare is recalling 17,228 SIGNA Artist MRI systems due to a potential defect in the cryogen ventilation system that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect

    GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI superconducting magnets recalled for improper cryogen venting

    GE Healthcare has recalled SIGNA Pioneer MRI systems due to potential cryogen ventilation defects that do not meet safety requirements. Approximately 17,228 devices are affected nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect

    GE Healthcare is recalling 17,228 of its 1.5T SIGNA HDe MR imaging systems because the cryogenic ventilation system does not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare MR superconducting magnets in SIGNA MRI systems may have cryogen ventilation systems that do not meet safety venting requirements. Approximately 17,228 systems are affected.

    Product
    GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE MRI superconducting magnet systems recalled for cryogen ventilation system defect

    GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MR system magnets recalled due to cryogen ventilation defect

    GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation

    GE Healthcare has recalled 17,228 MRI systems because the cryogenic ventilation system does not meet safety requirements. Systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI systems recalled for cryogen ventilation system defect

    GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling SIGNA Premier MRI systems due to a cryogen ventilation system that does not meet venting requirements. Approximately 17,228 affected devices were distributed worldwide.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation

    GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI systems recalled for cryogenic ventilation defect

    GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2022-02-16

    GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

    GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare SIGNA MR Systems cryogenic ventilation system defect recall

    GE Healthcare recalled approximately 17,228 SIGNA MR magnetic resonance imaging systems because the cryogenic ventilation systems may not meet proper venting requirements. The defect could create potential safety hazards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect

    GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects that may not meet safety venting requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MR Magnets Cryogenic Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MR superconducting magnet systems because the cryogenic ventilation system may not meet required venting standards.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI systems recalled for cryogen ventilation defect

    GE Healthcare is recalling certain MRI systems because the cryogen ventilation system does not meet venting requirements. The defect could affect safe operation of the MRI magnet.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibran
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI magnets recalled for cryogen ventilation defect

    GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states