Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, ra
FDA device recall Z-0907-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
- Action taken
- A recall notification letter, dated November 15, 2013, was sent to Users.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 147
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-11-15
- Date posted
- 2014-02-03
- Date terminated
- 2015-03-10
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM DEFINITION (K122471) | Siemens Medical Systems, Inc. | 2012-09-11 |
| SOMATOM DEFINITION EDGE (K120579) | Siemens Medical Systems, Inc. | 2012-05-23 |
| SOMATOM DEFINITION FLASH (K113342) | Siemens Medical Systems, Inc. | 2011-12-29 |
| SOMATOM DEFINITION AS (K103127) | Siemens Medical Solutions USA, Inc. | 2011-03-04 |