FDA-Device2012-09-12Class II

Siemens Mobilett Mira. Mobile X-Ray System.

Siemens Medical Solutions USA, Inc
Hazard

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

Sold states
Nationwide Distribution- including the states of GA, ID, IL, IA, KS, NC, OH, SD, TX, and WI.
Affected count
20
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens Mobilett Mira. Mobile X-Ray System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2012

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