FDA-Device2013-08-14Class II
Mobiletta Mira Mobile X-ray System
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
US Distribution including the states of IA, SD, NC, WI, OH, NE, TX, KS, ID, MI, GA, AR and IL.
Affected count
39
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Mobiletta Mira Mobile X-ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1875-2013Don't want to check this manually?
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