Recall Z-1383-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
| Date | Apr 9, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250 |
| Root cause | Nonconforming Material/Component |
| Action | Siemens initiated a recall/correction on February 16, 2012 by issuing Update Instruction XP056/11/S to the affected customers. All screws on the unit support on AXIOM Luminos dRF units will be replaced by a Siemens service engineer. For information regarding this recall call 610-219-4834. |
| Quantity | 2 |
| Distribution | Nationwide Distribution including California |
| 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 |