Apr

2015

SIGNA Systems , Cl II GE Healthcare

Company:GE Healthcare
Date of Enforcement Report: 4/1/2015
Class lI:

PRODUCT

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems. Recall Number Z-1305-2015

REASON
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI on 3/9/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
9,369 (2,937 US, 6,432 OUS).

DISTRIBUTION
Nationwide and Internationally.

___________________________________

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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SIGNA Systems , Cl II GE Healthcare

Amy Sellers

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