Device Recall HealthWay or CleanStation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Healthway Home Products, 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
    60968
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0933-2012
  • 사례 시작날짜
    2012-01-09
  • 사례 출판 날짜
    2012-01-31
  • 사례 상황
    Terminated
  • 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
    Cleaner, air, medical recirculating - Product Code FRF
  • 원인
    The company is recalling certain serial numbers of healthway model 20600-3 and cleanstation model cs20000 air purifiers because of a potential risk of electrical arcing that could cause overheating or fire within the units.
  • 조치
    Healthway Home Products, Inc. sent letters to distributors and end-users on January 9, 2012. The letter identified the product, the problem, and the action to be taken by the distributor. Distributors were instructed to immediately cease the distribution or sale of any of the HealthWay 20600-3, and CleanStation CS20000 units with the affected serial numbers. Distributors were also instructed to isolate any of these devices currently in their inventory in a secure area until they receive further instructions from the recalling firm. Distributors were asked to compile a list of end-users who purchased the product; this information is being provided to a third-party engaged to contact end-users on behalf of the recalling firm. --- End users are instructed to immediately stop using the product and go to www.airpurifierrecall.com and follow the prompts to enter the model number and serial number of the unit. If the unit is subject to the recall, the user will be asked to provide their name, address, and contact information. Users will receive a follow-up call from HealthWay to discuss the recall process. Customers that have purchased units with the serial numbers set forth below will have 3 options: (1) a retrofit of the unit, adding an arc-suppression circuit and a more robust high energy connector, at no cost; (2) a retrofit of the unit, adding an arc-suppression circuit and a more robust high energy connector, including a basic cleaning of the unit and new filter set for $99.99 (a 60% discount); or (3) a replacement, brand-new unit, including a remote control and 5-year limited warranty for $199.99 (an 85% discount). --- Customers without access to the internet or who to prefer to receive the information by mail may call 855.230.0401. --- On 01/19/2012, the firm began conducting field corrections by disabling the high energy zone on the HealthWay 10600-2 models. End users will be sent letters informing them to immediately stop using the device and contact the f

Device

  • 모델명 / 제조번호(시리얼번호)
    08070001-08070425, 01080001-01080420, 13070001-13070415, 10080001-10080455, 33070001-33070458, 21080001-21080355, 34070001-34070455, 22080001-22080420, 35070001-35070455, 28080001-28080455, 36070001-36070455, 21080001-21080190, 38070001-38070395, 47080001-47080410, 39070001-39070455, 49080001-49080423, 45070001-45070195, 50080001-50080420, 42070001-42070455, 35090001-35090447, 43070001-43070455
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Canada
  • 제품 설명
    Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. || The devices are intended to remove particles from the air for medical purposes
  • Manufacturer

Manufacturer

  • 제조사 주소
    Healthway Home Products, Inc., 4901 N Jefferson St, Pulaski NY 13142-4102
  • 제조사 모회사 (2017)
  • Source
    USFDA