Recall Z-0717-2011 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager)
| Date | Dec 17, 2010 (initiated Oct 25, 2010) |
| Status | Terminated |
| Reason | patient leg can be pinched |
| Root cause | Other |
| Action | SIEMENS sent a Customer Safety Advisory Notice dated October 25, 2010, to affected customers via Update Instructions AX072/10/S. The notice described the issue and the actions to be taken by customers. The customers were instructed to retain the annex together with their operating instructions and bring the hazard to the attention of their employees; inform all users and other persons of this notice; if they sold the device, forward this notice and attachment to the new owners of the device and provide SIEMENS with details of the new owners. If you have any questions, please contact +1-888-8 |
| Quantity | 24 units |
| Distribution | Nationwide distribution: CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NJ, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062623 | AXIOM LUMINOS DRF Siemens Medical Solutions USA, Inc., Aug 22, 2007 |