GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    66242
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2291-2013
  • 사례 시작날짜
    2013-08-13
  • 사례 출판 날짜
    2013-09-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Ge healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of discovery mr450, discovery mr750, and optima mr450w products. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed.
  • 조치
    GE Healthcare sent and Urgent Medical Device Correction letter dated August 13, 2013, to all affected consignees. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product correction and contact Information. Customers were instructed that the system may continue to be used as normal even with the yello foam protruding in the bore. Customers were told not to attempt to remove the yellow foam. Customers with questions were instructed to contact their local service representative if they have any questions concerning the notification. For questions regarding this recall call 262-513-4122.

Device

  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # 00000029854MR5 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290659MR2 00000290773MR1 00000290957MR0 00000291185MR7 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000292367MR0 00000292471MR0 00000292528MR7 00000292634MR3 00000292843MR0 00000293065MR9 00000293874MR4 00000294098MR9 00000294398MR3 00000294472MR6 00000294556MR6 00000294576MR4 00000294718MR2 00000295111MR9 00000295134MR1 00000295215MR8 00000296070MR6 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296300MR7 00000296369MR2 00000296429MR4 00000296462MR5 00000296469MR0 00000296626MR5 00000296829MR5 00000296840MR2 00000296841MR0 00000296860MR0 00000297134MR9 00000297147MR1 00000297355MR0 00000297387MR3 00000297493MR9 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298114MR0 00000298247MR8 00000298248MR6 00000298249MR4 00000298310MR4 00000298386MR4 00000298387MR2 00000298494MR6 00000298512MR5 00000298535MR6 00000298552MR1 00000298573MR7 00000298574MR5 00000298655MR2 00000298656MR0 00000298675MR0 00000298722MR0 00000298727MR9 00000298834MR3 00000298836MR8 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298932MR5 00000298943MR2 00000298959MR8 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299199MR0 00000299200MR6 00000299230MR3 00000299264MR2 00000299294MR9 00000299320MR2 00000299339MR2 00000299411MR9 00000299491MR1 00000299503MR3 00000299522MR3 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299952MR2 00000300038MR7 00000300039MR5 00000300122MR9 00000300296MR1 00000300473MR6 00000300493MR4 00000300494MR2 00000300564MR2 00000300565MR9 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300883MR6 00000300906MR5 00000300929MR7 00000300967MR7 00000300985MR9 00000301126MR9 00000301292MR9 00000301401MR6 00000301471MR9 00000302248MR0 00000302515MR2 00000302688MR7 00000302690MR3 00000302945MR1 00000303050MR9 00000303637MR3 00000304836MR0 00000304943MR4 00000305101MR8 00000305102MR6 00000305165MR3 00000305203MR2 00000305412MR9 00000305426MR9 00000305453MR3 00000305464MR0 00000305519MR1 00000305521MR7 00000305524MR1 00000306011MR8 00000306028MR2 000005148810-3 00000815BD3A44 00000837BD4DEA 00000837BD4E30 00000849BD53AB 00000849BD53A3 00000903BD55F2 00000913BD5A64 00000914BD5A84 00000918BD5B2E 00000918BD5B4E 00000919BD5BB2 00000919BD5B96 00000919BD5B99 00000926BD5CF6 00000931BD5D7E 00000933BD5E45 00000937BD5EF9 00000944BD6152 00000944BD6158 00000944BD6166 00000944BD6170 00000944BD6172 00000945BD617D 00000945BD617F 00000945BD6185 00000950BD62A5 00000950BD627E 00000950BD6283 00000952BD62E6 00001001BD6325 00001002BD63F2 00001002BD6371 00001002BD638E 00001002BD6393 00001003BD63F7 00001004BD643D 00001006XF510D 00001007BD6473 00001007BD648C 00001007BD6481 00001007BD6493 00001009BD65B4 00001009BD654B 00001009BD656E 00001009BD659D 00001009BD6591 00001009BD6593 00001010BD660A 00001011BD661D 00001011BD6630 00001011BD664A 00001011BD6658 00001012BD66A9 00001012BD66B6 00001012BD66CE 00001012BD66F2 00001018XF5027 00001018XF503B 00001018XF5039 00001026XF5154 00001026XF5155 00001026XF5173 00001026XF5175 00001026XF5178 00001026XF5191 00001027XF500C 00001027XF5004 00001027XF5018 00001046XF5004 00001048XF5028 00001049XF500C 00001049XF500F 00001049XF5004 00001049XF5005 00001049XF5007 00001049XF5008 00001049XF501A 00001049XF5011 00001049XF5014 00001049XF5019 00001050XF5015 00001050XF5017 00001050XF5020 00001050XF5024 00001051XF5039 00001052XF5031 00001052XF5053 00001052XF5096 00001101XF50AA 00001101XF50AD 00001101XF50BC 00001101XF50B0 00001101XF50B2 00001101XF50B6 00001101XF50B7 00001101XF50B8 00001101XF50C0 00001101XF502E 00001101XF502F 00001101XF5023 00001101XF503A 00001101XF503E 00001101XF5030 00001101XF504B 00001101XF5046 00001101XF5047 00001101XF505B 00001101XF5054 00001101XF5056 00001101XF5058 00001101XF5059 00001101XF5066 00001101XF507A 00001101XF507D 00001101XF5075 00001101XF5076 00001101XF5077 00001101XF5078 00001101XF508C 00001101XF508E 00001101XF5081 00001102XF50A2 00001102XF500A 00001102XF500F 00001102XF5003 00001102XF501B 00001102XF501D 00001102XF5019 00001102XF502C 00001102XF502F 00001102XF5022 00001102XF5023 00001102XF5025 00001102XF5029 00001102XF504D 00001102XF5046 00001102XF5072 00001102XF5073 00001102XF5074 00001102XF5076 00001104XF5022 00001105XF502C 00001105XF503D 00001105XF503E 00001105XF504A 00001105XF504D 00001105XF5044 00001105XF5046 00001106XF50CB 00001106XF50CC 00001106XF50C0 00001106XF50D1 00001106XF50EF 00001106XF50F2 00001106XF50F3 00001106XF50F7 00001106XF500A 00001106XF500B 00001106XF500C 00001106XF500F 00001106XF5001 00001106XF5003 00001106XF5009 00001106XF501B 00001106XF501D 00001106XF5010 00001106XF5014 00001106XF5016 00001106XF5019 00001106XF5020 00001106XF5024 00001106XF5028 00001106XF503C 00001106XF503F 000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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, . OUS: AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
  • 제품 설명
    GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . || scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • Manufacturer

Manufacturer

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