SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reco
FDA device recall Z-0971-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Artifacts are found in acquired imaging on the SOMATOM Force.
- Action taken
- A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 7
- Distribution
- PA, MA, MN, SC, MD, and TX.
- Date initiated
- 2014-12-03
- Date posted
- 2015-01-14
- Date terminated
- 2015-04-06
- 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 |