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.
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