SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model Number 73 93 114
FDA device recall Z-0158-05 · posted 2004-11-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 199 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Date initiated
- 2004-09-28
- Date posted
- 2004-11-03
- Date terminated
- 2008-09-04
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM P30 CT SYSTEMS (K013522) | Siemens Medical Systems, Inc. | 2001-11-07 |