Events

Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Swirl Technologies Pty Ltd T/A Parker Healthcare 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
    RC-2017-RN-00845-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00845-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has advised that some devices have excessive background noise. this has been determined to be caused by an issue with the transistor circuit.
  • 조치
    Complete the supplied Verification Facsimile/Email Reply Form and then return it as directed to Parker. If any of the investigated products have been transferred to another facility, please immediately let that facility know of this Recall for Product Correction, and record it on the Verification Facsimile/Email Reply Form. If the excessive noise is suspected to be present, or you have any Technical inquiry, please contact Parker Healthcare Service Department as directed. These units will be returned to the Manufacturer in the USA for product correction.

Device

Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular
  • 모델명 / 제조번호(시리얼번호)
    Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular ARTG Number: 128657 (Swirl Technologies Pty Ltd T/A Parker Healthcare - Ultrasound system, non-imaging, Doppler blood-flow measurement)Serial Number(s):Model: 3 MHz ObstetricSerial Number: CAQ0472
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA