Events

Device Recall TRUBalance3 Power Positioning System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pride Mobility Products Corp 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
    75881
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0942-2017
  • 사례 시작날짜
    2016-12-01
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151534
  • 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
    Wheelchair, powered - Product Code ITI
  • 원인
    The interface between the tb3 back and tilt base can separate when tilted beyond the specified angle.
  • 조치
    Pride Mobility Products Corp. mailed a letter to affected customers to inform them of the issue. Systems were not required to be returned. Customers were informed that a TB3 Seat Depth Adjustment Reinformcement Kit which contains (2) reinforcement plates and associated hardware to strengthen the interface will be installed to address the issue. Direct accounts were asked to contact patients to inform them of the product correction. Customers were also requested to complete and return Pride's completion card once the correction has been made. Pride will issue a $65.00 credit once the completion card is received. Customers with questions were instructed to call Pride's Upgrade Department at 866-222-6212. For questions regarding this recall call 800-800-8586.

Device

Device Recall TRUBalance3 Power Positioning System
  • 모델명 / 제조번호(시리얼번호)
    Numerous serial numbers affected (12,343 units)
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). || Mobility Medical Device
  • Manufacturer
    Pride Mobility Products Corp

Manufacturer

Pride Mobility Products Corp
  • 제조사 주소
    Pride Mobility Products Corp, 182 Susquehanna Ave, Exeter PA 18643-2653
  • 제조사 모회사 (2017)
    Pride Mobility Products Corp
  • Source
    USFDA