Company:Carestream Health Inc.
Date of Enforcement Report: 9/2/2015
Class lI:
PRODUCT
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015
REASON
Carestream became aware of an issue with its DRX Evolution System v5.7 DIRECTVIEW Software v5.6 and v5.7. It has been determined that there is a software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
RECALLING FIRM/MANUFACTURER
Carestream Health Inc, Rochester, NY on 8/7/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Domestic: 76 units, Foreign: 160 units
DISTRIBUTION
Nationwide and Internationally
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