Company: Carestream Health Inc.
Date of Enforcement Report:1/15/2014
Class lI:
PRODUCT
Carestream DRX-Revolution Mobile X-Ray System — Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 — The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Recall Number Z-0491-2014
REASON
It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
RECALLING FIRM/MANUFACTURER
Carestream Health Inc.,Rochester, NY on 8/29/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
310 systems
DISTRIBUTION
Nationwide.
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