FDA-Device2014-02-12Class II
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Siemens Medical Solutions USA, Inc
Hazard
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Sold states
Nationwide Distribution.
Affected count
147
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0907-2014Don'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