Skip to content
Recall Observatory FDA recall evidence

Device product

Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

Z-1848-2013

May 07, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    software version VD10A. The possibility exists that a software error