The Recall Desk

FDA (Devices) recall action 87023

GE Healthcare, LLC recalled 6 products on 2021-01-20

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
2021-01-20
Critical
0
Units
188

Why these products were recalled

GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

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

  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls Nuclear Medicine Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 52 nuclear medicine systems worldwide because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws

    GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.

    Product
    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls Discovery NM 630 and 830 Nuclear Medicine Cameras

    GE Healthcare is recalling 81 Discovery NM 630 and 830 units due to loose rotor bearing screws that could release a bearing.

    Product
    Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
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    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling seven Optima NM/CT 640 units because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Distribution
    0 states