Events

Device Recall WarmAir Model 135 Hyperthermia System and Blankets 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
    59691
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3119-2011
  • 사례 시작날짜
    2011-07-20
  • 사례 출판 날짜
    2011-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103341
  • 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, thermal regulating - Product Code DWJ
  • 원인
    Cincinnati sub-zero is conducting a field correction due to changes that have been made to the warmair model 135 devices operation and technical manuals in order to comply with fda device labeling regulations.
  • 조치
    Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached "Recall Response Form" via fax to (513) 772-9119 or scan and email to WA135manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241. For additional information the customers are provided with an e-mail address: WA135-2011@cszinc.com as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..

Device

Device Recall WarmAir Model 135 Hyperthermia System and Blankets
  • 모델명 / 제조번호(시리얼번호)
    The WarmAir Model 135 device has the 510(k) #K101148, and the literature associated with device Serial Numbers: 994-1350001 through 104-1356894, is subject to recall/correction.   Part Number: 86185 (100V WarmAir 135 device) 86186 (115V WarmAir 135 device) 86187 (230V/240V WarmAIr 135 device)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • 제품 설명
    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. || To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature 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