Events

Device Recall AdTech Electrode Connection System/Cables 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ad-Tech Medical Instrument 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
    73685
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1503-2016
  • 사례 시작날짜
    2016-03-29
  • 사례 출판 날짜
    2016-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144756
  • 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
    Electrode, depth - Product Code IKD
  • 원인
    Ad-tech is recalling unopened/unused sterile cables intended to be used only with all compatible ad-tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. this recall has been initiated due to package failures (i.E. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
  • 조치
    Consignees were sent a "Medical Device Recall" letter dated March 29, 2016. The letter described the problem and the product being recalled. Advised consignees to immediately examine their inventory, quarantine and return the product to AD-Tech. If the product has been further distributed identify customers and notify them of the recall. Requested consignees to complete and return the "Medical Device Recall Return Response" form to their Ad-Tech Clinical Specialist at customersupport@adtechmedical.com; FAX: 262-634-5668 or Telephone 262-634-1555. For questions contact Ad-Tech Clinical Specialist. .

Device

Device Recall AdTech Electrode Connection System/Cables
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
  • 제품 설명
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: || 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); || 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); || 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); || 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); || 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); || 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). || FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). || Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. || Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.
  • Manufacturer
    Ad-Tech Medical Instrument Corporation

Manufacturer

Ad-Tech Medical Instrument Corporation