Events

Rappel de Device Recall HealthWay or CleanStation

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Healthway Home Products, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60968
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0933-2012
  • Date de mise en oeuvre de l'événement
    2012-01-09
  • Date de publication de l'événement
    2012-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106910
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Cleaner, air, medical recirculating - Product Code FRF
  • Cause
    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.
  • Action
    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

Device Recall HealthWay or CleanStation
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada
  • Description du dispositif
    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
    Healthway Home Products, Inc.

Manufacturer

Healthway Home Products, Inc.
  • Adresse du fabricant
    Healthway Home Products, Inc., 4901 N Jefferson St, Pulaski NY 13142-4102
  • Société-mère du fabricant (2017)
    Healthway Home Products, Inc.
  • Source
    USFDA