Device Recall Bravo pH Monitoring capsule 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Given Imaging Ltd. 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
    61018
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0966-2012
  • 사례 시작날짜
    2012-01-11
  • 사례 출판 날짜
    2012-02-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-09-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, fetal ph - Product Code LLT
  • 원인
    Failure of the bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
  • 조치
    Given Imaging sent a Urgent Product Recall letter to all affected consignees. The letter identified the product, description of problem, actions to be taken and advised customers to read this important information packet in its entirety. Customers were advised to complete the Customer Response Sheet included and return per the instructions provided. Also attached to the letter was a Customer Bulletin: Update to Vacuum Settings. For questions call 1-800-448-3644 option 3.

Device

  • 모델명 / 제조번호(시리얼번호)
    FGS-0312 (5 pack), Lot numbers: 11775Q, 12064Q, 12227Q, 12333Q, 12389Q, 12440Q, 12475Q, 12494Q, 12643Q, 12545Q, 12769Q, 12770Q, 12840Q, 12896Q, 12897Q, 12928Q, 12989Q, 13026Q, 13056Q, 13109Q, 13109Q, 13162Q, 13164Q, 13208Q, 13233Q, 13246Q, 13282Q, 13283Q, 13371Q, 13390Q, 13462Q, 13461Q, 13540Q, 13569Q, 13634Q, 13679Q, 13695Q, 13700Q, 13712Q, 13716Q, 13753Q, 13777Q, 13786Q, 13798Q, 13799Q, 13813Q, 13836Q, 13867Q, 13894Q, 13937Q, 13979Q, 14064Q, 14101Q, 14120Q, 14141Q, 14230Q, 14255Q, 14265Q, 14284Q, 14338Q, 14400Q, 14419Q, 14423Q, 14458Q, 14491Q, 14542Q, 1457QQ, 14572Q, 14570Q, 14611Q, 14634Q, 14734Q, 14770Q, 14805Q, 14825Q, 14826Q, 14871Q, 15030Q, 15051Q, 15071Q, 15078Q, 15114Q, 15158Q, 15221Q, 15324Q, 15406Q, 15401Q, 15500Q, 15603Q, 15630Q, 15672Q, 15679Q, 15711Q, 15787Q, 15860Q, 15912Q, 15938Q, 15971Q, 15998Q, 16115Q, 16144Q, 16192Q, 16221Q, 16320Q, 16290Q, 16354Q, 16382Q, 16395Q, 16449Q, 16503Q, 16511Q, 16580Q, 16606Q, 16607Q, 16673Q, 16762Q, 16867Q, 16762Q & 16847Q and FGS-0313 (single pack), Lot numbers: 12647Q, 12765Q, 12797Q, 12902Q, 13234Q, 13458Q, 13608Q, 13632Q, 13635Q, 13751Q, 13868Q, 13907Q, 14011Q, 14065Q, 14231Q, 14339Q, 14402Q, 14612Q, 14761Q, 14783Q, 14865Q, 14984Q, 15222Q, 15538Q, 15698Q, 15766Q, 15937Q, 16392Q, 16194Q, 16398Q, 16707Q, 16879Q, 17058Q & 16912Q. Recall expanded on 02/20/2012 to include additional lot numbers: 17102Q, 17188Q and 17227Q.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Belgium, Brazil, Denmark, Canada, Cyprus, Finland, Germany, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Netherlands, Norway, New Zealand, Panama, Portugal, Singapore, Sri Lanka, South Africa, Spain Thailand, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). || Product Usage: || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Given Imaging Ltd., 5555 Oakbrook Pkwy, Norcross GA 30093-6254
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA