FDA-Device2012-08-01Class II

Siemens syngo.plaza. Radiological image processing system

Siemens Medical Solutions USA, Inc
Hazard

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

Sold states
(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Affected count
2
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Siemens syngo.plaza. Radiological image processing system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2078-2012

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