SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fro
FDA device recall Z-1933-2015 · posted 2015-06-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
- Action taken
- A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 40 total
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-06-04
- Date posted
- 2015-06-27
- Date terminated
- 2017-03-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 (K133424) | Siemens Medical Solutions USA, Inc. | 2014-01-17 |