Health o Meter Professional 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pelstar, Llc 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
    60031
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0294-2012
  • 사례 시작날짜
    2011-10-07
  • 사례 출판 날짜
    2011-11-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-11-30
  • 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
    Scale, stand-on, patient - Product Code FRI
  • 원인
    There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. this short may cause the batteries to smoke, burn or burst.
  • 조치
    Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model 498KL, UPC Code - 892076002718, Serial numbers 4980000001 through 4980002909
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.
  • 제품 설명
    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL || Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Pelstar, Llc, 11800 S Austin Ave, Unit B, Alsip IL 60803-3559
  • 제조사 모회사 (2017)
  • Source
    USFDA