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U.S. Department of Health and Human Services

Class 2 Device Recall HealthWay or CleanStation

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  Class 2 Device Recall HealthWay or CleanStation see related information
Date Initiated by Firm January 09, 2012
Date Posted January 31, 2012
Recall Status1 Terminated 3
Recall Number Z-0933-2012
Recall Event ID 60968
510(K)Number K012549  
Product Classification Cleaner, air, medical recirculating - Product Code FRF
Product 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
Code Information 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  
Recalling Firm/
Manufacturer		 Healthway Home Products, Inc.
4901 N Jefferson St
Pulaski NY 13142-4102
For Additional Information Contact
315-298-2904 Ext. 101
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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
Quantity in Commerce 9107 units
Distribution Worldwide Distribution - USA (nationwide) and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRF and Original Applicant = HEALTHWAY PRODUCTS, INC.
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