The Recall Desk

FDA (Devices) recall action 82982

GE Healthcare, LLC recalled 6 products on 2019-06-26

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2019-06-26
Critical
0
Units
6,678

Why these products were recalled

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

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.

1–6 of 6

  • SevereFDA (Devices)··2019-06-26

    GE Healthcare Recalls Discovery ML DR PET/CT Systems Due to Table Stop Defect

    GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-26

    GE Healthcare Recalls Discovery PET/CT 710 Systems Due to Table Stop Defect

    GE Healthcare is recalling 1,113 Discovery PET/CT 710 systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-06-26

    GE Healthcare Recalls Discovery ML PET/CT Systems Due to X-Ray Safety Defect

    GE Healthcare is recalling 1,113 Discovery ML PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-26

    GE Healthcare Recalls Discovery PET/CT 610 Systems Due to X-Ray Safety Issue

    GE Healthcare is recalling 1,113 Discovery PET/CT 610 systems because the table may stop moving while X-ray exposure continues.

    Product
    Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-06-26

    GE Healthcare Recalls Optima PET/CT Systems Due to X-Ray Exposure Hazard

    GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.

    Product
    Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-06-26

    GE Healthcare Discovery IQ PET/CT Systems Recalled for X-Ray Exposure Defect

    GE Healthcare is recalling 1,113 Discovery IQ PET/CT systems because the table may stop moving while X-ray exposure continues.

    Product
    Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Distribution
    0 states