FDA-Device2019-09-11Class II
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
Siemens Medical Solutions USA, Inc
Hazard
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
Sold states
Nationwide Foreign:
Affected count
2867 units worldwide (OUS); 1464 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2019Don't want to check this manually?
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