SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
FDA device recall Z-0107-2016 · posted 2015-10-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software and firmware bugs
- Action taken
- Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 21
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-08-18
- Date posted
- 2015-10-06
- Date terminated
- 2017-05-08
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM FORCE (K133589) | Siemens Medical Solutions USA, Inc. | 2014-04-17 |