Events

Fraxel Dual 1550/1927 Laser Systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Solta Medical Australia Pty Ltd 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-2014-RN-00402-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00402-1
  • 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
    Solta medical australia has determined that some customers may have obsolete versions of fraxel dual laser labelling (user manual and treatment settings card).The two obsolete documents incorrectly provided parameter settings for the treatment of melasma using the 1927 nm wavelength laser. only the 1550 nm wavelength has approved indications for use for the treatment of melasma.While both issues were corrected prior to 27 october, 2010, customers may not have received a corrected version of the labelling.-revision a of the 10-05170 re: store dual user manual, released on 27 august,2009 incorrectly stated the 1927 nm laser was indicated for melasma.This was corrected on revision b of 10-05170. -mk 3100 revisions a and b, fraxel re: store dual laser treatment settings card, effective from 2nd december 2009 - 27th october 2010 incorrectly stated the 1927 nm laser was indicated for melasma.This error was corrected on revision c of mk 3100.
  • 조치
    Solta Medical Australia is requesting their customers to return affected versions of the User Manual or Treatment Settings Card. Replacement information will be provided to customers.

Device

Fraxel Dual 1550/1927 Laser Systems
  • 모델명 / 제조번호(시리얼번호)
    Fraxel Dual 1550/1927 Laser SystemsModel Number: MC-SYS-SR1500-DMultiple serial numbers affectedARTG Number: 141041
  • Manufacturer
    Solta Medical Australia Pty Ltd

Manufacturer

Solta Medical Australia Pty Ltd
  • Source
    DHTGA