Events

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Registry nº10216710209, COMPUTERIZED TOMOGRAPHY EQUIPMENT Mx8000 DUAL vEXP PHILIPS BRAND, ANVISA Registry nº10216710142. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 PHILIPS MEDICAL SYSTEMS LTDA. 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
  • 사례 ID
    1232
  • 날짜
    2013-02-06
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    If the table is moved down unexpectedly, please discontinue use of the equipment and contact the Service Support of your local Philips equipment. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to sab from 7:00 a.m. to 7:00 p.m.
  • 원인
    Philips healthcare received field reports stating that the patient's desk in one system presented an unexpected descent movement while the patient was on it. philips has determined that the bed brake has malfunctioned due to deterioration of the vertical brake bolts. the following ct systems affected: • ct brilliance series: 6,10,16,16 power, 40, 64, big bore, big bore oncology, ict, ict sp, ingenuity core, ingenuity ct, mx8000 dual v. exp. there is a possibility that the vertical brake may fail while the patient is on the table and the table is raised. although no serious injury has been reported, if the vertical brake malfunctions, the technician, patient, or other persons near the table may be injured. system serial numbers brilliance ct 6 affected, access: http://portal.Anvisa.Gov.Br/wps/wcm/connect/109a64004e998c8aae88ae8a610f4177/aviso_de_seguranca_fco72800577.Pdf?mod=ajperes.
  • 조치
    The Philips Equipment Service Engineer will perform the brake repair or replace the system to solve the problem.

Device

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Re...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA