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.
- Company
- Shimadzu Medical Systems
- Recall Initiated
- April 3, 2014
- Posted
- May 8, 2014
- Terminated
- June 25, 2015
- Recall Number
- Z-1569-2014
- Quantity
- 685 units total (14 units in US)
- Firm Location
- Torrance, CA
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
Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Lot / Code Info
Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001
Root Cause
Software design
Action Taken
A Service Bulletin and a customer notification letter were sent on 4/3/2014 for all the customers who purchased the Shimadzu Digital X-Ray System (Catalog No. DAR-8000f). The notification informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.