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Recall Observatory FDA recall evidence

Device product

Siemens Mobilette Mira, intended use as Mobile x-ray system.

Z-0480-2013

October 10, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 63495
Status
Terminated
Classification
Class II
Quantity
21
Official record key
device-enforcement:Z-0480-2013

Official wording

Reason: There is a risk of lost images during examination.

Code information: Model Number 10273100

Distribution pattern: Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a risk of lost images during examination.