FDA Recall
Terminated
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Recall: Z-1848-2013
·
Initiated May 7, 2013
Recall
- Recall Number
- Z-1848-2013
- Event Number
- 65491
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 7, 2013
- Posted
- August 1, 2013
- Terminated
- December 24, 2013
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
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.
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.
Distribution
US Distribution including the states of CA, IN, NJ and OK.
Quantity
4