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Siemens Medical Solutions USA, Inc recalls SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fro
Recalled July 8, 2015 · FDA recall Z-1933-2015 · Siemens Medical Solutions USA
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. · FDA Class II
Units
40 total
Sold at
Nationwide Distribution.
Description
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.
Product
SOMATOM Emotion 16; 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →