Jun

2016

Discovery IGS 740, Cl II GE Healthcare

Company: GE Medical Systems, LLC
Date of Enforcement Report 6/1/2016
Class lI:

PRODUCT

GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy..
Recall Number Z-1707-2016

REASON
Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI on 4/15/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
54

DISTRIBUTION
Nationwide and Internationally

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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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Discovery IGS 740, Cl II GE Healthcare

Amy Sellers

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