Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to
FDA device recall Z-0321-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- software error - does not allow protocol to properly synchronize with ECG triggers
- Action taken
- The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 9 units
- Distribution
- Nationwide
- Date initiated
- 2008-09-03
- Date posted
- 2009-01-05
- Date terminated
- 2009-09-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM SENSATION 64 AND SENSATION CARDIAC (K040665) | Siemens Medical Solutions USA, Inc. | 2004-04-02 |