Events

Sunquest Encompass 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sunquest Information Systems, 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
    62751
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2243-2012
  • 사례 시작날짜
    2009-04-13
  • 사례 출판 날짜
    2012-08-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111640
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    Sunquest is recalling the sunquest encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when daylight saving time is active.
  • 조치
    The firm, Sunquest, sent a "Urgent-Product Safety Notice: PSN-09-01" letter dated April 13, 2009 all their customers who purchase the Sunquest Encompass versions 2.4 and later. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to request software correction and to create a service request via client support webpage at www.sunquestinfo.com/supportweb. Then choose Submit a Service Request. Select Issue Type and select Software Request. When Software Request is selected, the Work Queue field automatically fills in with "Software Request." Promptly advise appropriate personnel. Customers with questions can contact Client Support and Services at (877) 239-6337 for US and Canadian sites and at +44(0)0800-960-972 for international sites.

Device

Sunquest Encompass

Manufacturer

Sunquest Information Systems, Inc.
  • 제조사 주소
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • 제조사 모회사 (2017)
    Roper Technologies Inc
  • Source
    USFDA