Device Recall Lipoplasty 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
    77655
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3048-2017
  • 사례 시작날짜
    2017-06-01
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
  • 원인
    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. this only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
  • 조치
    Consignees were telephoned on June 1, 2017, as initial recall notification. At that time, all consignees agreed to discontinue use of the affected product until it was returned or repaired. An Urgent Medical Device Recall letter dated June 14, 2017, requested that consignees that have not been contacted regarding this recall and have a device repaired between the dates of 09/08/2016 and 05/23/2017 contact Solta Medical immediately at 877-782-2286. Any questions regarding the recall can be directed to Solta Medical Product Support Team at 877-782-2286 or 510-259-5299, option 2.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reference No. 110-0032; Shipping P/N P007014-03; Device P/N P007023-03; Serial No. 001CW9, 000V1W, 000VBK, VAS10-0135-SB, 001FM0, 000TJ5, 00190Q.
  • 유통
    US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
  • 제품 설명
    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA || The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Solta Medical Inc, 11720 N Creek Pkwy N Ste 100, Bothell WA 98011-8244
  • 제조사 모회사 (2017)
  • Source
    USFDA