Recall Z-1253-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.
| Date | May 6, 2009 (initiated Jan 8, 2009) |
| Status | Terminated |
| Reason | During interventional use and applications, the possibility exists for liquids to enter the systems. |
| Root cause | Equipment maintenance |
| Action | A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300. |
| Quantity | 669 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951358 | SIRESKOP SX Siemens Medical Solutions USA, Inc., May 15, 1995 |