GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR75

FDA device recall Z-1480-2014 · posted 2014-04-21 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize

Action taken

Consignees were sent on 4/2/2014 a GE Healthcare "Urgent Medical Device Correction" letter dated April 2, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information (Fore questions, contact your local service representative ).

Root cause

Process change control

Status

Terminated

Product code

LNH

Quantity affected

1,546 (704 US, 842 OUS).

Distribution

Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL,

Date initiated

2014-04-02

Date posted

2014-04-21

Date terminated

2015-04-08

Location

Waukesha, WI

Related 510(k) clearances