Company: Shimadzu Medical Systems
Date of Enforcement Report:5/14/2014
Class lI:
PRODUCT
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Recall Number Z-1569-2014
REASON
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances..
RECALLING FIRM/MANUFACTURER
Shimadzu Medical Systems, Torrence, CA on 4/3/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
685 units total (14 units in US)
DISTRIBUTION
Nationwide and Internationally
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