Recall Z-1533-2014— GE Healthcare, LLC

Name: FDA recall Z-1533-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-23

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-04-23, terminated 2015-01-21. It names 5 FDA 510(k) clearances: K103327, K103335, K091536 and 2 more. Product: GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.. Reason: GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-04-23
Terminated: 2015-01-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K103327 — DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation·cleared 2011-09-30
K103335 — GEM OPTION FOR 1.5 MRI SYSTEMSGE Healthcare·cleared 2011-03-07
K091536 — OPTIMA MR450WGe Medical Systems, LLC·cleared 2009-07-17
K083147 — DISCOVERY MR450Ge Medical Systems, LLC·cleared 2008-11-04
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 MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.

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