FDA-Device2012-09-05Class II

syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

Siemens Medical Solutions USA, Inc
Hazard

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Sold states
Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Affected count
14
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2275-2012

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