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Recall Observatory FDA recall evidence

Device product

Mobiletta Mira Mobile X-ray System

Z-1875-2013

May 02, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65605
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-1875-2013

Official wording

Reason: Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This

Code information: Model number 10273100

Distribution pattern: US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. When a Mobilett Mira is regularly exposed to extensive mechanical strain (driven over high thresholds for doors or elevators), it is possible that one of its main wheel shafts could break because of material fatigue, resulting in the chassis falling on the ground on the affected wheel side. This