Recall Z-0189-2010 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.
| Date | Nov 12, 2009 (initiated Sep 23, 2009) |
| Status | Terminated |
| Reason | possible injury to hand/fingers |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500. |
| Quantity | 14 units |
| Distribution | Nationwide Distribution -- FL, IL, MI, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960266 | SIREGRAPH CF Siemens Medical Solutions USA, Inc., Mar 11, 1996 |