Recall Z-0163-05 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534
| Date | Nov 3, 2004 (initiated Sep 28, 2004) |
| Status | Terminated |
| Reason | Calcium Scoring feature on this devices is not closing properly after patient's exams. |
| Root cause | Other |
| Action | The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue. |
| Quantity | 8 units |
| Distribution | The product was shipped to medical facilities nationwide and government account in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010938 | SYNGO MULTIMODALITY WORKSTATION Siemens Medical Solutions USA, Inc., Jun 26, 2001 |