The Recall Desk

FDA (Devices) recall action 62946

GE Healthcare, LLC recalled 2 products on 2012-09-19

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-09-19
Critical
0
Units
508

Why these products were recalled

Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.

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.

1–2 of 2

  • HighFDA (Devices)··2012-09-19

    GE Healthcare Recalls Optima XR200amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-19

    GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Distribution
    0 states