RecallRadar

FDA Device recall Z-2275-2012

syngo.plaza, Model number 10592457

On 2012-09-05 the FDA classified a Class II recall of syngo.plaza, Model number 10592457 by Siemens Medical Solutions Usa, citing there is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2275-2012
ClassificationClass II
Statusterminated
Initiated2012-07-18
Published2012-09-05
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2275-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.