Recall Z-1480-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
| Date | Apr 21, 2014 (initiated Apr 2, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Process change control |
| Action | Consignees were sent on 4/2/2014 a GE Healthcare "Urgent Medical Device Correction" letter dated April 2, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information (Fore questions, contact your local service representative ). |
| Quantity | 1,546 (704 US, 842 OUS). |
| Distribution | Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081028 | SIGNA 3.0T MR750 SYSTEM Ge Medical Systems, LLC, Apr 25, 2008 |
| K083147 | DISCOVERY MR450 Ge Medical Systems, LLC, Nov 4, 2008 |
| K091536 | OPTIMA MR450W Ge Medical Systems, LLC, Jul 17, 2009 |
| K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, Sep 30, 2011 |
| K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS GE Healthcare, Mar 7, 2011 |