BICOR POLYDOROS X-Ray System, Model number 6134667.
FDA device recall Z-0145-2009 · posted 2008-11-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Unintended movement of the system table and/or C arm.
- Action taken
- Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 5 UNITS
- Distribution
- Nationwide.
- Date initiated
- 2008-08-11
- Date posted
- 2008-11-04
- Date terminated
- 2012-12-21
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM (K940484) | Siemens Medical Solutions USA, Inc. | 1994-04-19 |