Recall Z-0251-2016 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Shimadzu Medical Systems
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
| Date | Sep 30, 2015 |
| Status | Terminated |
| Reason | The C-arm may interfere with the table top under certain circumstances. |
| Root cause | Software design |
| Action | An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. 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 | 26 units total (4 units in US) |
| Distribution | Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963888 | C-ARM TABLE IVS-100 Shimadzu Medical Systems, Dec 18, 1996 |