FDAFDA · Food and drugs·Recall number Z-0935-2013
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.
Published March 20, 2013 · Recall initiated: May 10, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- Serial Number 000000000R6708 00000241143MR7 00000027552MR4 00000028626MR7 00000028674MR1 00000262235MR5 00000272922MR6 00000273268MR3 00000273598MR3 00000273631MR2 00000273632MR0 00000274287MR2 00000274288MR0 00000274740MR0 00000274742MR6 00000274886MR1 00000274887MR9 00000275000MR8 00000275001MR6 00000275003MR2 00000275463MR8 00000275464MR6 00000275527MR0 00000275528MR8 00000275533MR8 00000275534MR6 00000275535MR3 00000275536MR1 00000275537MR9 00000275538MR7 00000275539MR5 00000276137MR7 00000276164MR1 00000276184MR9 00000276196MR3 00000276197MR1 00000276241MR7 00000276242MR5 00000276243MR3 00000276244MR1 00000276245MR8 00000276457MR9 00000276458MR7 00000276461MR1 00000276637MR6 00000276656MR6 00000276657MR4 00000276658MR2 00000276659MR0 00000276660MR8 00000276676MR4 00000276678MR0 00000276680MR6 00000277441MR2 00000277442MR0 00000277443MR8 00000277444MR6 00000277531MR0 00000277533MR6 00000277534MR4 00000277535MR1 00000277639MR1 00000277640MR9 00000277642MR5 00000277643MR3 00000277780MR3 00000277782MR9 00000277916MR3 00000277917MR1 00000277918MR9 00000277919MR7 00000278037MR7 00000278038MR5 00000278040MR1 00000278041MR9 00000278101MR1 00000278102MR9 00000278104MR5 00000278105MR2 00000278164MR9 00000278167MR2 00000278219MR1 00000278221MR7 00000278312MR4 00000278313MR2 00000278315MR7 00000278389MR2 00000278390MR0 00000278391MR8 00000278392MR6 00000278552MR5 00000278553MR3 00000278554MR1 00000278555MR8 00000278556MR6 00000278605MR1 00000278606MR9 00000278607MR7 00000278672MR1 00000278673MR9 00000278674MR7 00000278675MR4 00000278676MR2 00000278797MR6 00000278798MR4 00000278799MR2 00000278800MR8 00000278801MR6 00000279065MR7 00000279066MR5 00000279158MR0 00000279165MR5 00000279166MR3 00000279398MR2 00000279402MR2 00000279414MR7 00000279415MR4 00000279416MR2 00000279445MR1 00000279446MR9 00000279447MR7 00000279448MR5 00000279449MR3 00000279461MR8 00000279462MR6 00000279463MR4 00000279464MR2 00000279465MR9 00000279562MR3 00000279563MR1 00000279615MR9 00000279616MR7 00000279618MR3 00000279870MR0 00000279882MR5 00000279906MR2 00000279908MR8 00000279910MR4 00000280064MR7 00000280065MR4 00000280066MR2 00000280067MR0 00000280068MR8 00000280250MR2 00000280251MR0 00000280252MR8 00000280253MR6 00000280324MR5 00000280326MR0 00000280327MR8 00000280328MR6 00000280362MR5 00000280363MR3 00000280365MR8 00000280366MR6 00000280578MR6 00000280582MR8 00000280690MR9 00000280691MR7 00000280692MR5 00000280775MR8 00000280776MR6 00000280778MR2 00000280779MR0 00000280857MR4 00000280858MR2 00000280859MR0 00000280860MR8 00000280861MR6 00000280921MR8 00000280922MR6 00000280923MR4 00000281155MR2 00000281156MR0 00000281157MR8 00000281158MR6 00000281159MR4 00000281373MR1 00000281374MR9 00000281375MR6 00000281377MR2 00000281463MR0 00000281464MR8 00000281465MR5 00000281466MR3 00000281467MR1 00000281547MR0 00000281548MR8 00000281690MR8 00000281691MR6 00000281692MR4 00000281694MR0 00000281824MR3 00000281826MR8 00000281827MR6 00000281860MR7 00000281861MR5 00000281862MR3 00000281863MR1 00000281941MR5 00000281943MR1 00000282002MR5 00000282003MR3 00000282005MR8 00000282006MR6 00000282336MR7 00000282338MR3 00000282339MR1 00000282340MR9 00000282379MR7 00000282381MR3 00000282382MR1 00000282508MR1 00000282509MR9 00000282510MR7 00000282511MR5 00000282512MR3 00000282583MR4 00000282584MR2 00000282585MR9 00000282689MR9 00000282690MR7 00000282691MR5 00000282692MR3 00000282693MR1 00000282813MR5 00000282814MR3 00000282815MR0 00000282817MR6 00000282860MR6 00000282863MR0 00000282864MR8 00000282865MR5 00000282867MR1 00000282947MR1 00000282948MR9 00000282949MR7 00000282950MR5 00000282951MR3 00000283019MR8 00000283021MR4 00000283022MR2 00000283023MR0 00000283119MR6 00000283120MR4 00000283121MR2 00000283122MR0 00000283123MR8 00000283304MR4 0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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