Reported Sep 12, 2012 · Terminated

Siemens Mobilett Mira. Mobile X-Ray System.

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • Siemens Mobilett Mira. Mobile X-Ray System.
Lot codes and dates
    • 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
Amount recalled
20

Where it was sold

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 3, 2014 · Data as of Sep 19, 5:24 PM UTC

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