Recall Z-0101-2009 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that involve high skin doses, which can result in deterministic effects.
| Date | Oct 10, 2008 (initiated Aug 12, 2008) |
| Status | Terminated |
| Reason | Liquids may enter the system and cause potential malfunction and possible hazard to patients, user or other persons. |
| Root cause | Device Design |
| Action | The recalling firm was made aware of a potential problem with the device from the manufacturer in Germany. The recalling firm sent a copy of the Customer Safety Advisory Notice, dated June 18, 2008, received from Germany to their customers. The recalling firm has representatives visiting each location to modify the units. |
| Quantity | 211 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051602 | AXIOM SIRESKOP SD Siemens Medical Systems, Inc., Jul 7, 2005 |