Events

Device Recall GE Healthcare, Discovery MR750w 3.0T 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    72301
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0254-2016
  • 사례 시작날짜
    2015-08-31
  • 사례 출판 날짜
    2015-11-10
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140518
  • 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
    When performing head or neck scans, the currently displayed sar values could be lower than the actual sar in the head as predicted by sar modeling. the predicted head sar value from the modeling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.
  • 조치
    GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, Discovery MR750w 3.0T
  • 모델명 / 제조번호(시리얼번호)
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EM0225 00001250FMM01W EM0227 00001250FMM02U EM0228 00001250FMM02G EM0226 00001308FMM055 EM0231 00001308FMM04T EM0229 00001308FMM05B EM0234 00001308FMM063 EM0232 00001301FMM04H EM0235 00001236FMM04W EM0237 00001301FMM04V EM0233 00001236FMM04P EM0271 00001308FMM05M EM0272 00001236FMM01H EM0241 00001236FMM020 EM0240 00001250FMM02Y EM0236 00001308FMM027 EM0242 00001236FMM016 EM0238 00001236FMM05E EM0239 00001236FMM05U EM0246 00001309FMM06A EM0245 00001308FMM022 EM0244 000000HDMR4067 EM0260 00001309FMM08Y EM0243 00001309FMM05Y EM0247 00001308FMM01P EM0255 00001308FMM020 EM0256 00001308FMM03L EM0248 00001308FMM00E EM0253 00001309FMM09Y EM0257 00001308FMM012 EM0254 00001308FMM01Y EM0249 00001309FMM08H EM0258 00001308FMM01U EM0265 00001309FMM095 EM0275 00000000UA0358 EM0259 00000308840MR8 EM0261 00000309816MR7 EM0262 00000310059MR1 EM0270 00000310063MR3 EM0263 00000310420MR5 EM0266 00000310421MR3 EM0281 00000310474MR2 EM0267 00000310475MR9 EM0264 00000310677MR0 EM0268 00000310720MR8 EM0280  EM0278  EM0279 00000310702MR6 EM0277  EM0269  EM0273 00000310839MR6 EM0276 00000310903MR0 EM0274 00000310105MR2 KA1023MR02 00001233FMM06M 0850270414 00001204FMM04V 0850270386 00001227FMM00X 0850270411 00000000UA0170 0850270427 00001250FMM03E 0850270426 00000306791MR5 0850270430 00001221FMM06X 0850270409 00001308FMM02H 0850270436 00001309FMM04W 0850270446 00001309FMM055 0850270455 00001236FMM05A KW1005MR04 00001309FMM096 KW1019MR03 00000310542MR6 KW1100MR02 00000301969MR2 LB1331MR01 00001250FMM028 LB1160MR02 00001301FMM04M LB1006MR02 00000308183MR3 MR308183MR3 00001147FMM0E6 UDN0121 00000304860MR0 RTD0191 00001140FMM0G4 0920279031 00001308FMM052 85092252519 00000310773MR7 85110163303 00001250FMM02P 600042MR02 00001308FMM05H PL3116MR01 00001309FMM0AE PL3277MR01 00001308FMM05C QA1042MR01 00001204FMM04A RO1098MR02 00001234FMM0KG RU5599MR01 00000000UA0227 RU8438MR01 00000000UA0229 RU8438MR03 00001308FMM03B RU8615MR01 00001307FMM08M RU8792MR01 00000310164MR9 RU8937MR01 00000310220MR9 RU1717MR01 00001135FMM019 SA1033MR01 00001308FMM064 SA1223MR01 00001309FMM05E SA1255MR03 00000309329MR1 SA1058MR03 00000000UA0023 0847270026 00001142FMM096 MPX94401 00001309FMM08R UE929526 00000000UA0425 DPN36500 00001134FMM10D A010MR08 00001251FMM01P M001MR02 00001309FMM05J N002MR03 00000306343MR5 M004MR01 00000306349MR2 O009MR03 00000308132MR0 T002MR01 00001142FMM092 120810MR02 00000000UA0049 850020MR02 00001250FMM039 387040MR10 00001309FMM06W 725100MR02 00000309270MR7 150250MR01  259130MR12 00001308FMM048 0853270141 00000310604MR4 0856270071 00001204FMM04B 34348MRS01 00001227FMM00N 26001MRS01 00000000UA0349 53008MRS01 00000309272MR3 06162MRS01 00000000UA0097 AE1016MR01 00001111FMM0B7 70431MRS04 00001250FMM038 00010MRS02 00000000UA0265 00230MRS01 00001309FMM04T 10692MRS01 00001309FMM07M 77266MRS03 00000310701MR8 20312MRS01 00000302616MR8 10639MRS01 00000302669MR7 10678MRS01 00000309906MR6 MRUA0353
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
  • 제품 설명
    GE Healthcare, Discovery MR750w 3.0T. || Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
  • Manufacturer
    GE Healthcare

Manufacturer

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