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FDA Medical Device Recalls (openFDA)

Healthway Home Products, Inc.: 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

Recall number
Z-0933-2012
Recalling firm
Healthway Home Products, Inc.
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
Status
Terminated
Initiated
2012-01-09
Posted
2012-01-31
Terminated
not on file
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.
Root cause
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
9107 units
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Lot, serial or model codes
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
510(k) numbers
["K012549"]
PMA numbers
not on file
Product code
FRF
Firm FEI
1000634072
Firm city
Pulaski
Firm state
NY
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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