Recall Z-1569-2014 ยท IZI System, X-Ray, Angiographic
Shimadzu Medical Systems
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.
| Date | May 8, 2014 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052500 | DAR-8000F Shimadzu Medical Systems, Oct 17, 2005 |