Events

Device Recall Drager PT 4000 Phototherapy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical Systems, 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
    62470
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1950-2012
  • 사례 시작날짜
    2012-07-02
  • 사례 출판 날짜
    2012-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110720
  • 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
    Unit, neonatal phototherapy - Product Code LBI
  • 원인
    A routine internal quality check found that the drager pt 4000 phototherapy system is fitted with a 16 amp rated fuse instead of the specified 1.6 amp rated fuse. this may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. the possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. there have not b.
  • 조치
    Drager Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to bee taken by the customers. In addition, a Customer Reply Card was included for customers to complete and return. Contact the firm at 800-543-5047 for questions regarding this recall.

Device

Device Recall Drager PT 4000 Phototherapy System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-USA (nationwide) and Puerto Rico.
  • 제품 설명
    Drager PT 4000 Phototherapy System
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • 제조사 주소
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA