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

Recall Z-0125-2013 — GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

U.S. FDA — Device Enforcement · United States · 2012-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0125-2013
Date of alert
2012-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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