Recall Z-1585-2016 ยท IXR Table, Radiographic, Tilting
Shimadzu Medical Systems
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
| Date | Apr 28, 2016 (initiated Mar 31, 2016) |
| Status | Terminated |
| Reason | Report of unintentional movement of table to reverse tilting. |
| Root cause | Device Design |
| Action | Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers on April 8, 2016. Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray Diagnostic Table. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contacted Shimadzu National Technical Support at (800) 228-1429. Shimadzu will send out an updated customer notification letter to inform customers that the liquid penetration may cause an electrical short circuit, causing the table to unintentionall |
| Quantity | 185 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.