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-1934-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief