Recall Z-0818-05 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis MP X-Ray System
| Date | May 11, 2005 (initiated Apr 1, 2005) |
| Status | Terminated |
| Reason | potential problem with the fluoroscopy switch on the power grip |
| Root cause | Other |
| Action | The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button. |
| Quantity | 21 units |
| Distribution | The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp., Mar 30, 2001 |