May

2014

Shimadzu Digital Radiography Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Shimadzu Digital Radiography Cl II

Amy Sellers

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