FDA-Device2015-07-08Class II
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Siemens Medical Solutions USA, Inc
Hazard
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Sold states
Nationwide Distribution.
Affected count
40 total
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2015Don't want to check this manually?
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