FDA-Device2014-05-14Class II
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.
Shimadzu Medical Systems
Hazard
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Affected count
685 units total (14 units in US)
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1569-2014Don't want to check this manually?
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