AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic im
FDA device recall Z-1254-2009 · posted 2009-05-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During interventional use and applications, the possibility exists for liquids to enter the systems.
- Action taken
- A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 240 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-01-08
- Date posted
- 2009-05-06
- Date terminated
- 2009-09-01
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM SIRESKOP SD (K051602) | Siemens Medical Systems, Inc. | 2005-07-07 |