Events

Volcano SpinVision Sterile Equipment Cover 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Volcano Corp 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
    19957
  • 사례 시작날짜
    2016-03-29
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    Potential that the product may be labelled beyond its expiration date. a number of units at the manufacturing facility may have been shipped in a package with an inventory label containing an expiration date that is one or more months later than the correct expiration dates shown on the product's primary and secondary packaging., the primary packaging includes a label on each pouch containing individually packaged products. the secondary packaging, which is also the shipping box, also contains a label identifying the product by part and lot number., the correct expiration dates located on the labels of the primary and secondary packaging for these products is no earlier than march 2018, so prompt attention to this notice will prevent expired product from mistakenly remaining in inventory. while month and year are listed, the shelf life extends through the last day of the listed month.
  • 조치
    Manufacturer to issue advice regarding use

Device

Volcano SpinVision Sterile Equipment Cover
  • 모델명 / 제조번호(시리얼번호)
    Model: 891BG-10, Affected:
  • Manufacturer
    Volcano Corp

Manufacturer

Volcano Corp
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA