Events

Device Recall Philips HeartStart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    54282
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1135-2010
  • 사례 시작날짜
    2010-01-19
  • 사례 출판 날짜
    2010-03-15
  • 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=88133
  • 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
    internal defibrillator paddles - Product Code MKJ
  • 원인
    Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy.
  • 조치
    Philips issued Urgent Medical Device Recall notification to customers by letter on 1/25/10 via UPS advising of this defect and providing instructions on how to determine if they have a defective paddle. The customers will be assisted by field service engineers to remove and replace these defective units (those within the date range of September 1, 2008 to December 30, 2008). Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification. Removed units will be replaced free of charge and will be destroyed by Philips. Distribution of the Urgent Medical Device Recall Notification will be managed by Philips representatives in each affected geography. Customers are asked to follow the Actions to be taken by customer/user section of the Urgent Medical Device Recall Notification.

Device

Device Recall Philips HeartStart
  • 모델명 / 제조번호(시리얼번호)
    Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, Estonia, Finland, France, Georgia, Germany, HONG KONG, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Malaysia, Mauritius, Netherlands, NICARAGUA, Norway, Peru, Philippines, POLAND, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Turkey, UKRAINE, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. || Models: || M4741A - Extra Large Switched internal Paddles || M4742A - Large Switched internal Paddles || M4743A - Medium Switched internal Paddles || M4744A - Small Switched internal Paddles
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA