SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produc
FDA device recall Z-0604-2017 · posted 2016-11-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
- Action taken
- Siemens' sent a Customer Safety Advisory Notice letter dated October 19, 2016 to affected customers. The letter identified the affected product, problem, potential risks, how to avoid the potential risk related to this issue and actions to be taken.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 762 systems distrtibuted in U.S.
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-10-19
- Date posted
- 2016-11-17
- Date terminated
- 2017-03-13
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM Definition AS/AS+ (K143400) | Siemens Medical Solutions USA, Inc. | 2015-04-08 |