Events

Device Recall Hemotherm CE, model 400CE, HeaterCooling Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero Products Inc 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
    76718
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1825-2017
  • 사례 시작날짜
    2017-03-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154013
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • 원인
    Improperly rated fuses were used in the manufacture of the device.
  • 조치
    Letters were sent to customers and distributors instructing them to immediately cease use and/or further distribution of affected product, remove and discard the affected fuses and replace with the new fuses provided by CSZ, and complete and return the Field Action Response Form.

Device

Device Recall Hemotherm CE, model 400CE, HeaterCooling Device
  • 모델명 / 제조번호(시리얼번호)
    151-10283CE, 151-10284CE, 151-10285CE, 151-10286CE, 151-10287CE, 151-10290CE, 151-10291CE, 151-10292CE, 151-10293CE, 151-10294CE, 151-10295CE, 151-10296CE, 151-10297CE, 151-10298CE, 151-10299CE, 152-10300CE, 152-10301CE, 152-10302CE, 152-10303CE, 152-10304CE, 152-10310CE, 152-10311CE, 152-10312CE, 152-10313CE, 152-10314CE, 153-10321CE, 153-10322CE, 153-10323CE, 153-10324CE, 154-10335CE, 154-10336CE, 154-10337CE, 154-10338CE, 154-10339CE, 154-10340CE, 154-10341CE, 154-10342CE, 154-10343CE, 154-10344CE, 154-10345CE, 154-10346CE, 154-10347CE, 154-10348CE, 154-10349CE, 154-10350CE, 154-10351CE, 154-10352CE, 154-10353CE, 154-10354CE, 154-10355CE, 154-10356CE, 154-10357CE, 154-10358CE, 154-10359CE, 154-10360CE, 154-10361CE, 154-10362CE, 154-10363CE, 154-10364CE, 154-10365CE, 154-10366CE, 154-10367CE, 154-10368CE, 154-10369CE, 154-10370CE, 154-10371CE, 154-10373CE, 154-10374CE, 154-10375CE, 161-10376CE, 161-10377CE, 161-10378CE, 161-10379CE, 161-10380CE, 161-10381CE, 161-10382CE, 161-10383CE, 161-10384CE, 161-10385CE, 161-10386CE, 161-10387CE, 161-10388CE, 161-10389CE, 161-10390CE, 161-10391CE, 161-10392CE, 161-10393CE, 161-10394CE, 161-10395CE, 161-10397CE, 161-10398CE, 161-10399CE, 161-10400CE, 161-10401CE, 161-10402CE, 161-10403CE, 161-10404CE, 161-10405CE, 161-10406CE, 161-10407CE, 161-10408CE, 161-10409CE, 161-10410CE, 161-10411CE, 161-10412CE, 161-10413CE, 161-10414CE, 161-10415CE, 161-10416CE, 161-10417CE, 161-10418CE, 161-10419CE, 161-10420CE, 162-10426CE, 162-10427CE, 162-10428CE, 162-10429CE, 162-10430CE, 162-10431CE, 162-10432CE, 162-10433CE, 162-10434CE, 162-10435CE, 162-10436CE, 162-10437CE, 162-10438CE, 162-10439CE, 162-10440CE, 162-10441CE, 162-10442CE, 162-10443CE, 162-10444CE, 162-10445CE, 163-10446CE, 163-10447CE, 163-10448CE, 163-10449CE, 163-10450CE, 163-10456CE, 163-10457CE, 163-10458CE, 163-10460CE, 163-10461CE, 163-10462CE, 163-10463CE, 163-10464CE, 163-10465CE, 163-10466CE, 163-10467CE, 163-10468CE, 163-10469CE, 163-10470CE, 163-10471CE, 163-10472CE, 163-10473CE, 163-10474CE, 163-10475CE, 163-10476CE, 163-10477CE, 163-10478CE, 163-10479CE, 163-10480CE, 163-10481CE, 163-10482CE, 163-10483CE, 163-10484CE, 163-10485CE, 163-10486CE, 163-10487CE, 163-10488CE, 163-10489CE, 163-10490CE, 163-10491CE, 163-10492CE, 163-10493CE, 163-10494CE, 163-10496CE, 163-10497CE, 163-10498CE, 163-10499CE, 163-10500CE, 163-10501CE, 163-10502CE, 163-10503CE, 163-10504CE, 163-10505CE, 163-10506CE, 163-10507CE, 163-10508CE, 163-10509CE, 163-10510CE, 163-10511CE, 163-10512CE, 163-10513CE, 163-10514CE, 163-10515CE, 163-10521CE, 163-10522CE, 163-10523CE, 163-10524CE, 163-10525CE, 163-10526CE, 163-10527CE, 163-10528CE, 163-10529CE, 163-10530CE, 163-10585CE, 164-10531CE, 164-10532CE, 164-10533CE, 164-10534CE, 164-10535CE, 164-10536CE, 164-10537CE, 164-10538CE, 164-10539CE, 164-10540CE, 164-10541CE, 164-10542CE, 164-10543CE, 164-10544CE, 164-10545CE, 164-10546CE, 164-10547CE, 164-10548CE, 164-10549CE, 164-10550CE, 164-10552CE, 164-10553CE, 164-10554CE, 164-10555CE, 164-10556CE, 164-10557CE, 164-10558CE, 164-10559CE, 164-10560CE, 164-10561CE, 164-10562CE, 164-10563CE, 164-10564CE, 164-10565CE, 164-10566CE, 164-10567CE, 164-10568CE, 164-10569CE, 164-10570CE, 164-10571CE, 164-10572CE, 164-10573CE, 164-10574CE, 164-10575CE, 164-10576CE, 164-10577CE, 164-10578CE, 164-10579CE, 164-10580CE, 164-10581CE, 164-10582CE, 164-10583CE, 164-10584CE, 164-10587CE, 164-10588CE, 164-10589CE, 164-10590CE, 164-10591CE, 164-10592CE, 164-10593CE, 164-10594CE, 164-10595CE, 164-10596CE, 164-10597CE, 164-10598CE, 164-10599CE, 164-10600CE, 164-10601CE, 164-10602CE, 164-10603CE, 164-10604CE, 164-10605CE, 164-10606CE, 164-10607CE, 164-10608CE, 164-10609CE, 164-10610CE, 164-10613CE, 164-10614CE, 164-10615CE, 164-10616CE, 164-10617CE, 164-10618CE, 164-10619CE, 164-10620CE, 164-10621CE, 164-10622CE, 164-10623CE, 164-10624CE, 164-10625CE, 164-10626CE, 164-10627CE, 164-10629CE, 164-10630CE, 164-10631CE, 164-10632CE, 164-10633CE, 164-10634CE, 164-10635CE, 164-10636CE, 164-10637CE, 164-10638CE, 164-10639CE, 164-10640CE, 164-10641CE, 164-10642CE, 164-10643CE, 164-10644CE, 164-10645CE, 164-10646CE, 164-10647CE, 164-10648CE, 164-10649CE, 164-10650CE, 164-10651CE, 164-10652CE, 164-10653CE, 164-10654CE, 164-10655CE, 164-10656CE, 164-10657CE, 164-10658CE, 164-10659CE, 164-10660CE, 164-10661CE, 164-10662CE, 164-10663CE, 164-10664CE, 164-10665CE, 164-10666CE, 164-10667CE, 164-10669CE, 164-10670CE, 164-10671CE, 171-10672CE, 171-10673CE, 171-10674CE, 171-10675CE, 171-10676CE, 171-10677CE, 171-10678CE, 171-10679CE, 171-10680CE, 171-10681CE, 171-10682CE, 171-10683CE, 171-10684CE, 171-10685CE, 171-10686CE, 171-10687CE, 171-10688CE, 171-10689CE, 171-10690CE, 171-10692CE, 171-10693CE, 171-10694CE, 171-10695CE, 171-10696CE, 171-10697CE, 171-10698CE, 171-10699CE, 171-10700CE, 171-10701CE, 171-10702CE, 171-10703CE, 171-10704CE, 171-10705CE, 171-10706CE, 171-10707CE, 171-10708CE, 171-10709CE, 171-10710CE, 171-10711CE, 171-10712CE, 171-10713CE, 171-10714CE, 171-10715CE, 171-10716CE, 171-10717CE, 171-10718CE, 171-10719CE, 171-10720CE, and 171-10721CE
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.
  • 제품 설명
    Hemotherm CE, model 400CE, Heater-Cooling Device
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA