Events

Device Recall STERRAD NX Sterilization System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    76194
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1197-2017
  • 사례 시작날짜
    2017-01-09
  • 사례 출판 날짜
    2017-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152495
  • 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
    Sterilizer, chemical - Product Code MLR
  • 원인
    Advanced sterilization products (asp) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.
  • 조치
    Advanced Sterilization will send an Field Safety Notice dated January 9, 2017,to inform customers that Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. ASP is sending the letter to remind customers to follow the instructions in the STERRAD NX System Users Guide. Specifically, after cycle initiation, the user should only open the chamber door of the STERRAD NX System when prompted by the Graphical User Interface (GUI) per the Users Guide. Customers are instructed to complete and return the attached Business Reply Card (double-sided) for their acknowledgement within 3 business days of receipt of this notification letter via mail by using the pre-paid postage, by email at ASP5816@stericycle.com, or by fax to Stericycle: 8662297775. For questions regarding the business reply card, customers are instructed to contact Stericycle at (877) 497- 2425 and reference event # 5816. For further questions regarding this recall please call (949) 453-6400,

Device

Device Recall STERRAD NX Sterilization System
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
  • 제품 설명
    STERRAD NX Sterilization System, Product Code: 10033, 10033-002
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA