SOMATOM Definition AS system, x-ray, tomography, computed
FDA device recall Z-0373-2017 · posted 2016-11-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
- Action taken
- Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 57 systems distributed in USA
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-10-19
- Date posted
- 2016-11-08
- Date terminated
- 2017-03-13
- 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 |