—#112211

Product

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

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111912
Affected lot / code info: Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide Distribution including the states of: GA, IA, KS, NC and TX.

Timeline

Recall initiated: 2012-04-30
Posted by FDA: 2012-09-11
Terminated: 2012-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.