Z-1569-2014 Class II Terminated

Recalled by Shimadzu Medical Systems — Torrance, CA

Recall Details

Product Type
Devices
Report Date
May 14, 2014
Initiation Date
April 3, 2014
Termination Date
June 25, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
685 units total (14 units in US)

Product Description

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.

Reason for Recall

Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.

Code Information

Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001