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

26–32 of 32

  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI systems recalled over improper cryogen ventilation

    GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.

    Product
    GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MR superconducting magnets recalled due to cryogen ventilation system defect

    GE Healthcare has recalled 17,228 MR superconducting magnets used in nuclear magnetic resonance imaging systems because the cryogen ventilation system does not meet required venting standards. The recall affects devices distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX 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 SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.

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

    GE Healthcare MRI Cryogen Ventilation System Defect Recall

    GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems

    GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect

    GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.

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

    GE Healthcare Optima MR430s MRI systems have potential cryogenic ventilation defect

    GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.

    Product
    GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
    Category
    Distribution
    2 states