Recall Z-0201-2019— GE Medical Systems, LLC

Name: FDA recall Z-0201-2019
Creator: U.S. Food and Drug Administration
Published: 2015-12-07

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-07, terminated 2018-11-08. It names 4 FDA 510(k) clearances: K142361, K142085, K132376 and 1 more. Product: GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.. Reason: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-07
Terminated: 2018-11-08
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 on FDA's record

K142361 — Discovery MR750 3.0TGe Medical Systems, LLC·cleared 2014-12-05
K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5TGe Medical Systems, LLC·cleared 2014-09-26
K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)·cleared 2013-11-15
K081028 — SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC·cleared 2008-04-25

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, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.

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