Recall Z-1732-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
| Date | May 28, 2010 (initiated Apr 12, 2010) |
| Status | Terminated |
| Reason | sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system. |
| Root cause | Device Design |
| Action | Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237. |
| Quantity | 83 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 |