Device Recall Guardian Services 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Imaging 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
    53133
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0168-2010
  • 사례 시작날짜
    2009-07-31
  • 사례 출판 날짜
    2009-11-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-01-08
  • 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
    Digital Image Storage Radiological Device - Product Code LMB
  • 원인
    Product serving as data backup protection does not contain 100% data backup for all netpractice customers on a daily basis.
  • 조치
    Firm notified consignees by an Urgent: Device Correction letter, dated July 31, 2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also provides Stryker's recommendations for reducing risk to patients. Technical instructions on the backup storage for the NetPractice are included with the letter. Stryker will not bill customers for the Guardian Service until the problem is remediated and Stryker notifies customers. If there are questions, customers should contact Stryker at 972-410-7100.

Device

  • 모델명 / 제조번호(시리얼번호)
    All accounts that have NetPractice and are signed up for Guardian Services backup.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). || The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Imaging, 1410 Lakeside Pkwy Ste 600, Flower Mound TX 75028-4027
  • 제조사 모회사 (2017)
  • Source
    USFDA