The Recall Desk

FDA (Devices) recall action 70649

Carestream Health, Inc. recalled 2 products on 2015-04-15

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
2015-04-15
Critical
0
Units
—

Why these products were recalled

Units device head descended unexpectedly

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2015-04-15

    Carestream CS 8100 3D Dental X-Ray Devices Recalled for Unexpected Head Descent

    Carestream Health is recalling 470 CS 8100 3D dental X-ray units because the device head may descend unexpectedly, posing a risk of injury to patients or operators.

    Product
    CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic su
    Category
    Distribution
    46 states
  • SevereFDA (Devices)··2015-04-15

    Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent

    Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.

    Product
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support
    Category
    Distribution
    46 states