ClearanceBrief
Recall Z-1305-2015 ยท LNH System, Nuclear Magnetic Resonance Imaging

GE Healthcare

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

DateMar 20, 2015 (initiated Mar 9, 2015)
StatusTerminated
ReasonGE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Root causeSoftware Manufacturing/Software Deployment
ActionGE Healthcare sent an "Urgent Medical Device Correction" letter dated March 9, 2015, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact your local service representative or call 800-437-1171 (available 24 hours a day).
Quantity9,369 (2,937 US, 6,432 OUS).
DistributionWorldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOI
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K0122001.5T INFINITY TWINSPEED MR SYSTEM
GE Medical Systems, Aug 3, 2001
K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
GE Medical Systems, Jan 24, 2002
K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
General Electric Co., Mar 28, 2003
K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEM
General Electric Co., Apr 14, 2004
K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
Ge Medical Systems, LLC, Jun 17, 2004