Events

Device Recall ThermiSense model 5700A5 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Salter Laboratories, Division of Regulatory Affairs 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
    57504
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1028-2011
  • 사례 시작날짜
    2010-12-21
  • 사례 출판 날짜
    2011-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96395
  • 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
    Monitor, breathing frequency - Product Code BZQ
  • 원인
    The incorrect length and connector were utilized in lot 110810 of the thermisense alice 5, making the product unusable as it will not interface with the sleep labs equipment.
  • 조치
    Salter Laboratories, Inc. sent an URGENT PRODUCT RECALL LETTER dated December 20, 2010, to all affected customers. The letter identfied the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for this product and lot number. Contact Salter to arrange for the return of the product. Complete the attached reply form, confirming receipt of the letter, and fax it back to Salter Labs at 1-800-628-4690. For questions regarding this recall call 661-854-3166.

Device

Device Recall ThermiSense model 5700A5
  • 모델명 / 제조번호(시리얼번호)
    Lot 110810
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
  • 제품 설명
    ThermiSense model 5700-A5 || The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs

Manufacturer

Salter Laboratories, Division of Regulatory Affairs
  • 제조사 주소
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA