Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2852-2016 — Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

U.S. FDA — Device Enforcement · United States · 2016-08-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2852-2016
Date of alert
2016-08-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Reported risk: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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