Recall Z-0933-2012 ยท FRF Cleaner, Air, Medical Recirculating
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
| Date | Jan 31, 2012 (initiated Jan 9, 2012) |
| Status | Terminated |
| 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 |
| Quantity | 9107 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM Healthway Products, Inc., Feb 4, 2002 |