SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
FDA device recall Z-2624-2016 · posted 2016-08-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
- Action taken
- Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1 unit
- Distribution
- Distributed to: MI, NY, CA, KY, ND, NE
- Date initiated
- 2016-07-13
- Date posted
- 2016-08-23
- Date terminated
- 2017-01-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM Definition AS Open (VA48) (K143409) | Siemens Medical Solutions USA, Inc. | 2015-03-26 |