Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in
FDA device recall Z-1569-2014 · posted 2014-05-08 · Terminated
Recall details
- Recalling firm
- Shimadzu Medical Systems
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity 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.
- Date initiated
- 2014-04-03
- Date posted
- 2014-05-08
- Date terminated
- 2015-06-25
- Location
- Torrance, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAR-8000F (K052500) | Shimadzu Medical Systems | 2005-10-17 |