Axiom Artis MP, Model number 5904466 angiographic x-ray systems
FDA device recall Z-0483-2010 · posted 2009-12-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- c-arm may tilt
- Action taken
- The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 70 units
- Distribution
- Nationwide
- Date initiated
- 2009-10-26
- Date posted
- 2009-12-03
- Date terminated
- 2010-01-26
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |