Events

Device Recall HiResolution Bionic Ear System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Bionics Corporation 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
    34873
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0759-06
  • 사례 시작날짜
    2006-03-08
  • 사례 출판 날짜
    2006-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44983
  • 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
    Cochlear Implant - Product Code MCM
  • 원인
    Certain hires 90k cochlear implants could fail as a result of elevated moisture levels. the unimplanted hires 90k implants listed are being removed from the market. patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
  • 조치
    The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.

Device

Device Recall HiResolution Bionic Ear System
  • 모델명 / 제조번호(시리얼번호)
    Model CI-1400-02H. Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714, 350754, 350859, 350964, 350998, 351006, 351031, 351035, 351063, 351129, 351132, 351139, 350568, 350121, 350486, 350514, 350581, 350655, 350896, 350955, 350958, 350967, 350452, 350816, 350949, 350959, 350963, 351021, 351140, 350489, 350492, 350505, 350555, 350789, 350910, 250914, 350957, 351036, 350565, 351020, 350251, 350283, 350482, 350509, 350519, 350524, 350525, 350527, 350531, 350532, 350583, 350676, 350689, 351046, 350535, 350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294, 351069.
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide to: AR, AL, FL, TX, NY, NE, NC, CO, GA, OH, IL, PA, IN, MN, NC, CA, HI, MA, AZ, VA, OR, SD, MI, MO, IA, UT, TN. Worldwide to: Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cuba, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela.
  • 제품 설명
    The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • 제조사 주소
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA