SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray tra
FDA device recall Z-0020-2016 · posted 2015-10-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
- Action taken
- A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 113 total
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-08-14
- Date posted
- 2015-10-05
- Date terminated
- 2016-12-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM Definition Flash (VA48) (K143416) | Siemens Medical Solutions USA, Inc. | 2015-04-16 |