Picis ED PulseCheckSoftware 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Picis 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
    59737
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3160-2011
  • 사례 시작날짜
    2011-08-01
  • 사례 출판 날짜
    2011-09-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-06-27
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • 원인
    Software does not display appropriate allergy interaction warning.
  • 조치
    Picis issued notification on 08/01/11 to affected clients, explaining the potential for the error, with instructions to monitor documented patient allergies closely when prescribing medication orders in ED PulseCheck, using Muitum drug database content. Picis will track the progress on acknowledgement of notification letter receipt through the implementation of software upgrade, for all potentially affected Customers. For questions regarding this recall call 781-557-3000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Service Pack v5.0 L and M
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Picis ED PulseCheck-Software, transmission & storage, patient data || Service Pack v5.0 L and M || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Picis Inc., 100 Quannapowitt Parkway, Suite 405, Wakefield MA 01880
  • 제조사 모회사 (2017)
  • Source
    USFDA