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Terminated

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

FDA Recall Z-0935-2013 · Posted 2013-03-11

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2011-05-10
Date Terminated2016-06-30
Product Quantity4026 (1672 US; 2354 OUS)

Reason for Recall

An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

Firm Action

GE Healthcare sent an Urgent Field Safety Notice dated May 5, 2011, to all affected customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to open only one patient report at a time when editing a report in SR Viewer. US Customers did not receive a customer letter, however all US systems have been updated. For questions customers were instructed to contact their local Sales/Service Representative. For questions regarding this recall call 262-513-4122.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091536OPTIMA MR450WGe Medical Systems, LLC · 2009-07-17K083147DISCOVERY MR450Ge Medical Systems, LLC · 2008-11-04K081028SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC · 2008-04-25K052978GE 1.5T SIGNA HDE MR SYSTEMGe Medical Systems, LLC · 2005-11-09K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMGe Medical Systems, LLC · 2005-09-21

Official Source

View FDA Recall →

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

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