Axiom Artis MP X-Ray System
FDA device recall Z-0818-05 · posted 2005-05-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- potential problem with the fluoroscopy switch on the power grip
- Action taken
- The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 21 units
- Distribution
- The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.
- Date initiated
- 2005-04-01
- Date posted
- 2005-05-11
- Date terminated
- 2005-08-18
- 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 |