Events

Recall of Device Recall HealthWay or CleanStation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Healthway Home Products, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0933-2012
  • Event Initiated Date
    2012-01-09
  • Event Date Posted
    2012-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106910
  • Notes / Alerts
    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.
  • Extra notes in the data
    Cleaner, air, medical recirculating - Product Code FRF
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada
  • Product Description
    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.
  • Manufacturer Address
    Healthway Home Products, Inc., 4901 N Jefferson St, Pulaski NY 13142-4102
  • Manufacturer Parent Company (2017)
    Healthway Home Products, Inc.
  • Source
    USFDA