Events

Quadra Assura 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical 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
    80212
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2324-2018
  • 사례 시작날짜
    2018-04-16
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164888
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • 원인
    The firm is releasing new firmware for high voltage implantable cardiac devices (icd) and cardiac resynchronization therapy defibrillators (crt-d) intended to strengthen security by providing an additional layer of protection against unauthorized device access. for older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the rf communication capability in these devices.
  • 조치
    On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.

Device

Quadra Assura
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    U.S. Nationwide distribution
  • 제품 설명
    Quadra Assura, Sterile EO, Model #/ Part #: || CD3265-40/100042335, 100059846; || CD3265-40Q/100042336, 100059847; || CD3267-40/100042956, 100043569, 100059961, 100078810; || CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; || CD3365-40C/100080435, 100080436; || CD3365-40Q/100080426, 100080427; || CD3367-40/100078813, 100079497, 100096097; || CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; || CD3367-40Q/100078851, 100079212, 100079504, 100096098; || CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; || CD3385-40C/100080778; || CD3385-40QC/100080780, 100105489
  • Manufacturer
    St Jude Medical Inc.

Manufacturer

St Jude Medical Inc.
  • 제조사 주소
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA