Oct

2012

GE Healthcare Seno Advantage 2.2 workstation Cl ll

Company:GE Healthcare LLC.
Date of Enforcement Report 10/31/12
Class ll:

PRODUCT

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. Recall Number Z-0125-2013

REASON
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.

RECALLING FIRM/MANUFACTURER
GE Healthcare LLC., Waukesha , WI on 5/24/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12

DISTRIBUTION
Nationwide and countries of TAIWAN, ITALY, CANADA, and BAHRAIN

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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GE Healthcare Seno Advantage 2.2 workstation Cl ll

Amy Sellers

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