Events

Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX8000 Dual, MX8000 Dual EXP, MX8000 IDT and MX8000 IDT 10 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    15027
  • 사례 시작날짜
    2013-07-19
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    The ct system phantom supplied with the above-listed scanners has a special pin by which the customer can check the low contract (lc) detectability for quality assurance. this pinconsists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon., the lc test is performed by visually inspecting the sectionand selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use. the manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable., the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.
  • 조치
    Instructions for use to be updated

Device

Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX80...

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA