Events

Device Recall Fraxel re:store Dual Laser System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Solta Medical, Inc. 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
    57595
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1010-2011
  • 사례 시작날짜
    2010-12-15
  • 사례 출판 날짜
    2011-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96741
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Powered laser surgical instrument with microbeam\fractional output - Product Code ONG
  • 원인
    The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
  • 조치
    The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.

Device

Device Recall Fraxel re:store Dual Laser System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
  • 제품 설명
    Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. || Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA || The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
  • Manufacturer
    Solta Medical, Inc.

Manufacturer

Solta Medical, Inc.
  • 제조사 주소
    Solta Medical, Inc., 25881 Industrial Blvd, Hayward CA 94545-2991
  • 제조사 모회사 (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA