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Terminated

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

FDA Recall Z-1305-2015 · Posted 2015-03-20

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-03-09
Date Terminated2015-09-08
Product Quantity9,369 (2,937 US, 6,432 OUS).

Reason for Recall

GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 9, 2015, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact your local service representative or call 800-437-1171 (available 24 hours a day).

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY. GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAHHSTAN,KENYA,REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMA N,PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SIERRA LEONE, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UGANDA , UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM and ZAMBIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC · 2004-06-17K040444GE SIGNA 3.0T WITH EXCITE MR SYSTEMGeneral Electric Co. · 2004-04-14K030874GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGeneral Electric Co. · 2003-03-28K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems · 2002-01-24K0122001.5T INFINITY TWINSPEED MR SYSTEMGE Medical Systems · 2001-08-03

Official Source

View FDA Recall →

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

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