The Recall Desk

FDA (Devices) recall action 67047

Carestream Health, Inc. recalled 3 products on 2014-01-29

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-01-29
Critical
0
Units
—

Why these products were recalled

Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 X-Ray Systems Recalled

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 diagnostic x-ray systems due to a potential for unexpected device movement.

    Product
    DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and
    Category
    Distribution
    23 states
  • HighFDA (Devices)··2014-01-29

    Carestream DRX-Evolution X-Ray Systems Recalled for Unexpected Movement

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 systems due to a risk of unexpected device movement.

    Product
    DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray tab
    Category
    Distribution
    23 states
  • HighFDA (Devices)··2014-01-29

    Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk

    Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.

    Product
    DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray ta
    Category
    Distribution
    23 states