Recall Z-1480-2014— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-04-02, terminated 2015-04-08. It names 5 FDA 510(k) clearances: K103327, K103335, K091536 and 2 more. Product: GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.. Reason: 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.
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-02
- Terminated
- 2015-04-08
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K103327 — DISCOVERY MR750W 3.0T
- K103335 — GEM OPTION FOR 1.5 MRI SYSTEMS
- K091536 — OPTIMA MR450W
- K083147 — DISCOVERY MR450
- K081028 — SIGNA 3.0T MR750 SYSTEM
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 MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.