Events

Device Recall Century Console Base 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Salyer Prn Biomedical 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
    64383
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0902-2013
  • 사례 시작날짜
    2013-01-31
  • 사례 출판 날짜
    2013-03-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115964
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    Concerns that the addition of the ups battery backup to the century console base shelf did not comply with the fda premarket notification regulations.
  • 조치
    An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232.

Device

Device Recall Century Console Base
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of MA,CA, and WI.
  • 제품 설명
    Century Console Base, Model #043625051b. || Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
  • Manufacturer
    Salyer Prn Biomedical

Manufacturer

Salyer Prn Biomedical
  • 제조사 주소
    Salyer Prn Biomedical, 1833 W Main St Ste 116, Mesa AZ 85201-6924
  • Source
    USFDA