FDAFDA · Food and drugs·Recall number Z-1569-2014
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.
Published May 14, 2014 · Recall initiated: April 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shimadzu Medical Systems
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
- Lot
- Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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