Events

Regenesis Biomedical PROVANT Wound 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Regenesis Biomedical 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
    50230
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0887-2009
  • 사례 출판 날짜
    2009-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75023
  • 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
    diathermy, shortwave - Product Code ILX
  • 원인
    In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. as such, for these few devices, the effectiveness of provant therapy may be impaired.
  • 조치
    Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.

Device

Regenesis Biomedical PROVANT Wound
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    WY, VA, and NC
  • 제품 설명
    Regenesis Biomedical PROVANT Wound || Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
  • Manufacturer
    Regenesis Biomedical Inc

Manufacturer

Regenesis Biomedical Inc
  • 제조사 주소
    Regenesis Biomedical Inc, 1435 N Hayden Rd, Scottsdale AZ 85257-3773
  • 제조사 모회사 (2017)
    Regenesis Biomedical
  • Source
    USFDA