Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scan

FDA device recall Z-3025-2017 · posted 2017-08-02 · Terminated

Recall details

Recalling firm: GE Medical Systems, LLC
Reason for recall: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Action taken: Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative.
Root cause: Mixed-up of materials/components
Status: Terminated
Product code: LNH
Quantity affected: 68 units in total
Distribution: US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
Date initiated: 2017-05-11
Date posted: 2017-08-02
Date terminated: 2020-09-09
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618)	Ge Medical Systems, LLC	2016-06-09
Discovery MR750 3.0T (K142361)	Ge Medical Systems, LLC	2014-12-05
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)	Ge Medical Systems, LLC	2014-09-26
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T (K132376)	Ge Healthcare (Ge Medical Systems, LLC)	2013-11-15
SIGNA 3.0T MR750 SYSTEM (K081028)	Ge Medical Systems, LLC	2008-04-25