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Carestream Health Inc. recalls Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street R
Recalled March 12, 2014 · FDA recall Z-1127-2014 · Carestream Health
Hazard
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. · FDA Class II
Units
Domestic: 347 units (total for both)
Sold at
Worldwide distribution. USA (nationwide) and the country of Canada.
Description
Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
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, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Manufacturer(s)
Carestream Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →