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Terminated

GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.

FDA Recall Z-1480-2014 · Posted 2014-04-21

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-04-02
Date Terminated2015-04-08
Product Quantity1,546 (704 US, 842 OUS).

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

Firm 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 ).

Root Cause

Process change control

Distribution Pattern

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 POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA,INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103327DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation · 2011-09-30K103335GEM OPTION FOR 1.5 MRI SYSTEMSGE Healthcare · 2011-03-07K091536OPTIMA MR450WGe Medical Systems, LLC · 2009-07-17K083147DISCOVERY MR450Ge Medical Systems, LLC · 2008-11-04K081028SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC · 2008-04-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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