Events

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Siemens 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-09-30
  • 사례 출판 날짜
    2014-09-30
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: siemens clinitek status, clinitek status+, and clinitek status connect systems medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning clinitek status, clinitek status+, and clinitek status connect systems, manufactured by siemens. the material numbers of affected products are identified as follows: clinitek status+: 10379675; 10379676; 10379677; 10379678; 10379679; 10379680; 10379681; 10697813; 10376324 (legacy p/n: 1780), clinitek status connect system: 10376322; 10376323 (legacy p/n: 1790); 10470849 (legacy p/n: 1797), clinitek status power supply adaptor – spare part: 10378632; 10378633; 10378634;10309177; 10309178; 10324040; 10376820 this affects power supply adaptors embossed with the numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, and 23140. the manufacturer has received customer complaints regarding damage to the external power supply adaptors that accompany the clinitek status, clinitek status+, and clinitek status connect urine analyzers, which can result in an increased potential for electric shock to the user. affected users are advised to discard all affected/ damaged adaptors. for clinitek status or clinitek status+ customers, instrument can still be run by battery power. affected users are suggested to consult operator’s guide for instructions. clinitek status connect systems, however, cannot be operated on battery power. for details, please refer to the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Siemens CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Manufacturer
    Siemens

Manufacturer

Siemens