FDA-Device2016-11-16Class II

SOMATOM Definition Flash system, x-ray, tomography, computed

Siemens Medical Solutions USA, Inc
Hazard

Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts.

Sold states
Nationwide Distribution
Affected count
57 systems distributed in USA
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Definition Flash system, x-ray, tomography, computed

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0374-2017

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