FDA Device

Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system

Hazard

During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t

What You Should Do

Remedy

Siemens has issued an Update Instruction XP018/12S in April 2012 to all affected consignees notifying them of the problem. The update instruction provides a correction of the wheel fixation. For questions call Siemens at 610-219-4834 or 610-448-4634.

Products

Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Brand
Siemens Medical Solutions USA, Inc
UPC
Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054

Units Affected

9