FDAFDA · Alimentos y medicamentos·N.º oficial Z-1305-2015
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
Publicado el 1 de abril de 2015 · Inicio del retiro: 9 de marzo de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare
- Distribuidor
- 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.
- Lote
- Mfg Lot or Serial # System ID 00000301098MR0 AL4023MR01 AL4004MR01 AL4009MR01 00000346726YM3 DZ1004MR01 000000HDMR5247 DZ1009MR02 00000267807MR6 DZ1057MR01 00001251FMM01J DZ1006MR01 00000305201MR6 DZ1101MR01 000000HDMR6342 DZ1250MR01 00000002790M24 DZ1396MR01 00000000175M20 DZ1102MR01 00000311125HM9 DZ1072MR01 00000004368M27 DZ1547MR01 00000003534M25 DZ1339MR02 00000005640M28 DZ1339MR01 00001010BD6611 DZ1090MR01 00000015868GQ3 DZ1259MR01 00001011BD667C DZ1005MR01 00000272532MR3 DZ1193MR01 00000005809M29 DZ1598MR01 00000311119HM2 DZ1061MR01 000000HDMR5358 DZ1260MR01 00000290691MR5 DZ1261MR01 00000172500MR1 DZ1033MR02 00000004987M24 DZ1064MR02 00000005787M27 DZ1204MR01 00000009356GQ7 DZ1128MR01 00000306373MR2 DZ1525MR01 00000005637M24 DZ1605MR01 00000099206HM5 DZ1149MR01 00000180852MR6 4406SIGNAMRI 00000002740M29 MRR8513 00000291189YM9 34874SIGNA 00000005153M22 MRR9924 00000147993MR0 132HORIZON 00000305908MR6 MRHM0559 00000305909MR4 MRHM0560 00001011BD6688 16683THDX 00000006310M27 MRR9946 00000301223MR4 2918179MR 00000012619GQ3 4954MR15T 00000011311GQ8 2214SIGNA15 000000000Z001A 221SIGCONT 00000939BD5F5E 2835341HDX 00000014403GQ0 4365SIGNA15 00000012946GQ0 4127SIGNA15 00000014002GQ0 4732SIGNAHDX 00000010316GQ8 4786SIGNA15 00000290572MR7 4867SIGEXC1 00000332881HM2 MRR9196 00000004700M21 MRR9081 00000193354MR8 17SIGNACVI 00000170215MR8 482180SIGNA 00000340717HM8 MRR9358 00000001413M24 2906536HDE 00000332884HM6 MRR9174 00000070159MR9 71727SIGNAGS 00000000471M23 221HORIZONLX 000000000R3122 MRR3122 00000015549GQ9 4291EXC15T 00000082246MR0 6124SIGN05 000000HDMR6209 422SIGNA3T 00001308FMM01X MRHM0774 00000147586MR2 2722620SIG15 000000000R4968 4224INFINITY 00000346339HM5 MRR9496 00000000045M25 264EXCHDE 00000004105M23 MRR9061 00000440464YM6 341CONTOUR 00000088583MR0 4224SIGN15 00000015657GQ0 341SIGNA15 00000291190YM7 90CONTOUR 00000005526M29 MRR9669 00000340794HM7 MRR9372 00000088108MR6 1253SIGN05 00001309FMM08P MRUA0343 000000000R4601 MRR4601 00000360302HM4 MRR9725 00000124312HM0 4821PROF 00000127836HM5 4127PROF5 00000127838HM1 2322PROFILE 00000139823HM9 2637068PROEX 00000144315HM9 4832PROFILE 00000146546HM7 3783TCPROFILE 00000155614HM1 2644212PROEXC 00000161775HM2 2974PROFILE 00000162013HM7 381452PROEXC 00000162757HM9 2944PROFILE 00000164001HM0 378PROFILE 00000165746HM9 2688289PROF 00000167867HM1 4637PROFILE 00000169093HM2 4656PROFILE 00000169839HM8 2716760PRO 00000173927HM5 2715407SIGNA 00000190360HM8 3442PROFILE 00000190928HM2 4664PROFILEA 00000191140HM3 106PROFHD 00000200586HM6 27454PROF 00000200905HM8 3752PROFILE 00000203041HM9 1871PROFHD 00000220572HM2 422PROFILE 00000223184HM3 4291PROF3 00000237538HM4 2965PROIDECH 00000239006HM0 2861360PRO 00000242122HM0 34874PROF 00000262864HM2 2840304PROF 00000263642HM1 2901849MR 00000268655MR8 341OVATION 00000378053YM3 174288PROF 00000267463MR8 0910272012 00000000858M21 0910272073 00000167474MR6 0910273016 00000113894MR0 0910273009 002003-0811-08 0910272041X 00000163869MR1 0910272025 00000254376MR7 0910272059 00001236FMM012 0910272093 00000303451MR9 0910272085 00001011BD663A 0910272072 00000014419YR6 0910272075 00000013616GQ8 0910272047 00000216270MR9 0910272035 00000291429MR9 0910274032 00000280725MR3 0910274012 00000010570GQ0 0910274016 00001309FMM04B 83109684989 00001406NMM0AU 83115138353 00000005683M28 83101071304 00000006230M27 83114336196 00000001528M29 0910273042 00000014860GQ1 0910274026 00000145162MR4 0910272020 00000003099M29 0910272088 00000014688GQ6 0910274021 00000011438GQ9 0910273039 00000283546MR0 0910273026 00001203FMM0VW 0910273043 00000278795MR0 0910273029 00000280570MR3 0910273001 00000001808M25 0910273041 00000269041MR0 0910272044 00000296056MR5 0910277004 00000000167M27 0910272060 00000072679YM4 0910274002 00000159114MR8 0910272023 00000914BD5A88 0910272041 00000212850MR2 0910272034
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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