FDA-Device2013-03-20Class II

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.

GE Healthcare, LLC
Hazard

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

Sold states
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.
Affected count
4026 (1672 US; 2354 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2013

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