Skip to content
Recall Observatory FDA recall evidence

Device product

Siemens Mobilett Mira. Mobile X-Ray System.

Z-2322-2012

August 21, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 63042
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-2322-2012

Official wording

Reason: 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

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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