Recall Z-1305-2015— GE Healthcare

Name: FDA recall Z-1305-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-09

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-03-09, terminated 2015-09-08. It names 5 FDA 510(k) clearances: K041476, K040444, K030874 and 2 more. 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. 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: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Terminated: 2015-09-08
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K041476 — GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC·cleared 2004-06-17
K040444 — GE SIGNA 3.0T WITH EXCITE MR SYSTEMGeneral Electric Co.·cleared 2004-04-14
K030874 — GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGeneral Electric Co.·cleared 2003-03-28
K013636 — SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems·cleared 2002-01-24
K012200 — 1.5T INFINITY TWINSPEED MR SYSTEMGE Medical Systems·cleared 2001-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.