25
Sep
2013

Advantage Workstation, Cl ll GE Healthcare

0

Company: GE Healthcare, LLC
Date of Enforcement Report: 9/25/2013
Class ll:

PRODUCT

GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Recall Number Z-2241-2013

REASON
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on3/272012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
318 (28 USm 290 OUS)

DISTRIBUTION
Nationwide and Internationally

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About the author

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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