Events

Device Recall WarmAir Model 135 Convective Warming 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
    59023
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2888-2011
  • 사례 시작날짜
    2011-06-01
  • 사례 출판 날짜
    2011-07-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100848
  • 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
    Thermal Regulating System - Product Code DWJ
  • 원인
    Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
  • 조치
    Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 12, 2011 to all affected customers. The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a "Recall Response Form". For additional information e-mail WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810.

Device

Device Recall WarmAir Model 135 Convective Warming Device
  • 모델명 / 제조번호(시리얼번호)
    100V - Part Number: 86185; 115V - Part Number: 86186; and 230V - Part Number 86187.   Serial Numbers: 032-1351178 thru 104-1356908 and 104-1356910 to 104-1356915.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    WarmAir Model 135 Convective Warming Device, || Cincinnati Sub-Zero Products, Inc. || Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket
  • 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
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA