Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2275-2012

July 18, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 62679
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-2275-2012

Official wording

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

Code information: Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Distribution pattern: Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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