The Recall Desk

FDA (Devices) recall action 80563

GE Healthcare Japan Corporation recalled 4 products on 2018-08-29

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-08-29
Critical
0
Units
92

Why these products were recalled

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

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

1–4 of 4

  • HighFDA (Devices)··2018-08-29

    GE Healthcare Optima CT660 Systems Recalled for Damaged Cable Hazard

    GE Healthcare is recalling Optima CT660 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSS
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2018-08-29

    GE Healthcare Optima CT660 Recall for Damaged Cable Electrical Hazard

    GE Healthcare is recalling Optima CT660 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 66
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2018-08-29

    GE Healthcare Recalls CT Systems Due to Damaged Cable Electrical Hazard

    GE Healthcare is recalling specific CT systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 6
    Category
    Distribution
    44 states
  • HighFDA (Devices)··2018-08-29

    GE Healthcare Optima CT540 Systems Recalled for Damaged Cable Hazard

    GE Healthcare is recalling Optima CT540 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA
    Category
    Distribution
    44 states