Device product
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Z-1848-2013
Product summary
- Event
- Event 65491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-1848-2013
Official wording
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.
Code information: Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
Distribution pattern: US Distribution including the states of CA, IN, NJ and OK.
Derived failure modes
-
Device software or design
software version VD10A. The possibility exists that a software error