Company: Carestream Health Inc.
Date of Enforcement Report: 8/21/2013
Class ll:
PRODUCT
Carestream DRX Evolution System, X-ray system — The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Recall Number Z-1877-2013
REASON
To a potential for an x-ray exposure technique change.
RECALLING FIRM/MANUFACTURER
Carestream Health Inc., Rochester, NY on 8/3/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US: 44 units; Foreign: 243 units
DISTRIBUTION
Nationwide and Internationally
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