PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 14, 2014 Initiated: April 3, 2014 #Z-1569-2014

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.

Details

Recalling Firm
Shimadzu Medical Systems
Units Affected
685 units total (14 units in US)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Shimadzu Medical Systems. Units affected: 685 units total (14 units in US).
Why was this product recalled?
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2014. Severity: Moderate. Recall number: Z-1569-2014.