Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
FDA device recall Z-0860-2012 · posted 2012-01-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.
- Action taken
- Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 1
- Distribution
- Product distributed in one hospital in California.
- Date initiated
- 2011-12-12
- Date posted
- 2012-01-25
- Date terminated
- 2014-01-14
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARISTOS FX PLUS (K061054) | Siemens Medical Solutions USA, Inc. | 2006-05-09 |