Recall Z-1312-2010 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392. Intended use: Angiographic x-ray system.
| Date | Apr 8, 2010 (initiated Feb 16, 2010) |
| Status | Terminated |
| Reason | Communication problems can occur which may result in unavailability of Bypass Fluoro. |
| Root cause | Device Design |
| Action | The recalling firm issued a Customer Safety Advisory Notice dated 2/16/10 to inform their customers of the problem. The letter identified the affected product and stated that the problem had been solved by the service technician by the time that customers would receive the letter. The letter also explained when the problem occurred and the possible risks associated with it. In addition, the firm stated what will be done to avoid the problem. |
| Quantity | 640 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS Siemens Medical Solutions USA, Inc., Jun 6, 2002 |