The Recall Desk

FDA (Devices) recall action 67349

Carestream Health Inc. recalled 2 products on 2014-03-12

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
2014-03-12
Critical
0
Units
694

Why these products were recalled

Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

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)··2014-03-12

    Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure

    Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.

    Product
    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-03-12

    Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage

    Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.

    Product
    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray…
    Category
    Distribution
    0 states