Events

Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical PM, 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
    38472
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1240-2007
  • 사례 시작날짜
    2007-07-18
  • 사례 출판 날짜
    2007-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53824
  • 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 - Product Code DQA
  • 원인
    Phantom pacer spikes caused by a damaged resistor.
  • 조치
    Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.

Device

Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor
  • 모델명 / 제조번호(시리얼번호)
    Catalog number/ serial number: 3404001/AI05110052/ AI05120000/ AI05120011/ AI05120012/ AI05120013/ AI05120018/ AI06060015/ AI06070047/ AI06100004/ AI06100005/ AI06100006/ , 3404001S/AI05110000/ AI05110001/ AI05110002/ AI05110003/ AI05110004/ AI05110005/ AI05110006/ AI05110007/ AI05110008/ AI05110009/ AI05110010/ AI05110011/ AI05110012/ AI05110013/ AI05110014/ AI05110015/ AI05110016/ AI05110017/ AI05110018/ AI05110019/ AI05110020/ AI05110021/ AI05110022/ AI05110023/ AI05110024/ AI05110025/ AI05110026/ AI05110027/ AI05110028/ AI05110029/ AI05110030/ AI05110031/ AI05110032/ AI05110033/ AI05110034/ AI05110035/ AI05110036/ AI05110037/ AI05110038/ AI05110039/ AI05120010/ AI05120016/ AI05120017/ AI05120019/ AI06010042/ AI06010043/ AI06060003/ AI06060004/ AI06060005/ AI06060006/ AI06060007/ AI06060008/ AI06060009/ AI06060010/ AI06060011/ , 3404002/AI05090021/ AI05090024/ AI05110049/ AI05120015/ AI06010035/ AI06010036/ AI06010049/ AI06040000/ AI06040001/ AI06040002/ AI06040003/ AI06040004/ AI06040005/ AI06040006/ AI06040007/ AI06040008/ AI06040009/ AI06040010/ AI06040011/ AI06040012/ AI06040013/ AI06040014/ AI06040015/ AI06040016/ AI06040017/ AI06040018/ AI06040020/ AI06060012/ AI06060013/ AI06060014/ AI06060017/ AI06060018/ AI06060019/ AI06060020/ AI06070037/ AI06070038/ AI06070039/ AI06070040/ AI06070042/ AI06070043/ AI06070044/ AI06070045/ AI06090053/ AI06100011/ AI06100012/ AI07010057/ AI07010058/ , 3404002E/AI05110040 AI05110041/ AI05110042/ AI05120001/ AI05120002/ AI05120005/ AI05120006/ AI05120007/ AI05120008/ AI05120009/ AI05120024/ AI06010041/ AI06010044/ AI06010045/ AI06010046/ AI06010048/ AI06040019/ AI06040023/ AI06040024/ AI06070041/ AI06070046/ AI06070048/ AI06070049/ AI06090050/ AI06090051/ , 3404002F/AI07010067/ AI07010068/ , 3404002G/AI05110050/ AI05110051/ AI05120003/ AI05120004/ AI06060021/ AI06060022/ AI06060023/ AI06070035/ AI06070036/ AI06090054/ AI06090055/ AI06090056/ AI06090057/ AI06090058/ AI06100008/ AI06100009/ AI06100010/ AI06100018/ , 3404002S/AI05110043/ AI05110044/ AI05110045/ AI06010037/ AI06010038/ AI06010039/ AI06010040/ AI06060000/ AI06060001/ AI06060002/ AI06060016/ AI06090052/ AI06100019/ AI06100020/ AI06100021/ AI06100022/ AI06100023/ AI06100024/ AI07010050/ AI07010051/
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.
  • 제품 설명
    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • 제조사 주소
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA