Device Recall GE Healthcare Signa Ovation 0.35T

  • 모델명 / 제조번호(시리얼번호)
    Model Number: 2276937;   Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5;   Model Number: 5118172;  Serial Numbers; 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1;  Model Number: 2377062-2;  Serial Number: 00000963007YM0;  Model Number: 2377062-5;  Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5;  Model Number: 2377062-8;  Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8; and  Model Number: 5148725;  Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275, 00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4.
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  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.
  • 제품 설명
    GE Healthcare Signa Ovation 0.35T, Model Numbers: || Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). || The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA