Recall Z-1848-2013 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
| Date | Aug 1, 2013 (initiated May 7, 2013) |
| Status | Terminated |
| Reason | Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected. |
| Root cause | Software design |
| Action | Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300. |
| Quantity | 4 |
| Distribution | US Distribution including the states of CA, IN, NJ and OK. |
| 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 |