Recall Z-0860-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
| Date | Jan 25, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| Reason | Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type. |
| Root cause | Process control |
| Action | Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit. |
| Quantity | 1 |
| Distribution | Product distributed in one hospital in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061054 | AXIOM ARISTOS FX PLUS Siemens Medical Solutions USA, Inc., May 9, 2006 |