—#112355

Product

Siemens Mobilett Mira. 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, 1053, 1057, 1070, 1079, 1081, 1088, 1098, 1099, 1102, 1103, 1105, 1106, 1107, 1108, and 1112.

Why it was recalled

During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover. This may cause the system to continuously move. In response, Siemens has issued Update Instruction XP038/12/S to r

Root cause (FDA determination)

Device Design

Action the firm took

Siemens initiated their correction of the MOBILETT Mira on August 21, 2012 by sending an "UPDATE INSTRUCTIONS XP038/12/S to all affected customers. The Instruction identifies the product, problem, and work steps for customers to follow. A XP038/12/S Completion Protocol letter was included for customers to complete and file with the instruction once the update is completed.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.

Timeline

Recall initiated: 2012-08-21
Posted by FDA: 2012-09-06
Terminated: 2014-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.