Announcements are listed in descending order from the most recent date. Please scroll down to read previous announcements.

Updated 6 Oct. 2023

Together with five independent, certified testing laboratories, Philips Respironics conducted extensive testing. Based on the results to date, Philips Respironics concluded that use of its sleep therapy devices are not expected to result in appreciable harm to health in patients. The FDA stated that the testing is extensive and conducted with independent parties and expressed no concerns with the validity or objectivity of the testing. Philips Respironics is still in discussions with the FDA on the details of further testing.

Update 16 May 2023

Philips has published the results of tests and research to assess the risk of deterioration of the sound insulation materials in Philips brand CPAP/BiPAP machines and has provided the results to the US FDA. The tests were conducted by an independent accredited laboratory. 5 locations and the said test results are reviewed and evaluated by external experts and medical institutions.

“The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices indicate that potential patient exposure to foam particulates and volatile organic compounds (VOCs) from the polyester-based polyurethane (PE-PUR) foam within the breathing gas pathway of these devices is unlikely to result in an appreciable harm to health in patients.”

Full Test Result Report

Updated 25 July 2022

Two studies in France and Canada In conclusion, no evidence was found of increased risk of carcinogenicity in users of Philips CPAP machines who have been using them for more than 7 years.

Details of study results in France

Details of study results in Canada

Update 17 June 2021

Since June 16, 2021, the company has been informed about the possibility of deterioration of sound absorbing foam in Philips CPAP/BiPAP machines. The company has started contacting all customers directly by phone. so that customers are aware of such problems and notify the company's measures to deal with the following problems:

  1. Every customer who buys a Philips machine from us is less than 5 years old, so the probability of encountering such a problem is very small. for comfort You can send the machine back to us to help check the condition of the foam and others as per the contact details below.
  2. The company will deliver bacteria and virus filters. (Bacterial/viral filter) for all customers who use Philips machines, 2 pieces each.* For use with the machine while waiting for new foam replacement However, the received 2 pieces of bacteria and virus filters can be used for 2 months (1 piece per month).
    *Connecting a Bacterial/viral filter may decrease the air pressure you receive. If you use an automatic pressure regulator (DreamStation Auto CPAP, DreamStation Go Auto CPAP, Dorma 500 Auto CPAP) The machine automatically compensates for pressure. If you use a constant pressure type machine (DreamStation CPAP Pro, DreamStation BiPAP S/T, DreamStation BiPAP AVAPS, BiPAP A40). Consult your doctor for proper pressure adjustment (if necessary).
  3. If the company has already received a new foam Will contact you again to make an appointment to change the foam next.

The company has contacted all customers directly to clarify and answer various questions. If any of you have not been contacted by our staff You can contact us at no. 02-460-9241, 02-462-6441, 02-462-6442 or Line: @nksleepcare or click on the button below We will contact you as soon as possible.

Announced on 16 June 2021

According to NK Sleep Care Co., Ltd., the official distributor of Philips CPAP/BiPAP machines in Thailand. Was informed by Philips USA that a possible deterioration of sound abatement foam was found in 0.03% of CPAP/BiPAP machines sold worldwide. The deterioration of the material has resulted in black powder coming out of the machine while it is in use. It is noticeable that such problems are likely to occur with devices that are more than 5 years old.

On June 14, 2021, Philips notified the dealer about the policy to resolve such problems. The soundproof material will be replaced with a new type of silicone foam for all CPAP and BiPAP machines free of charge.

In addition, Philips recommends that while waiting for this new type of foam to be replaced. in case it is Life-sustaining ventilator and doctor advised not to stop using the machine. Let the patient continue to operate the machine by using it in conjunction with an inline bacterial filter.

In this regard, NK Sleep Care Co., Ltd. is not indifferent. And has closely followed up and coordinated with Philips to speed up the delivery of new soundproofing materials, which are Silicone Foam, to be replaced for all customers who buy the device from the company. urgently And in the meantime, the company has temporarily suspended the trial service of Philips CPAP/BiPAP machines. Until the test unit has been replaced with a new foam.

From now on, the company will begin to contact all customers directly. To clarify the details and measures to solve this problem for everyone to know.

If you would like to inquire further, please call. 02-460-9241, 02-462-6441, 02-462-6442 or Line: @nksleepcare

The company apologizes for the aforementioned problems. and ask all customers to be confident that the company not calm And will expedite solving such problems in every possible way to bring your CPAP/BiPAP machine back to the best standard of use.

Yours sincerely
Kongsak Suwanarak
managing director
NK Sleepcare Co., Ltd.

Affected Models

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Affected version 1
Affected version 2
Affected version 3

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Affected version 4
Affected version 5
Affected version 6

Only for NK Sleepcare customers who have purchased a Philips CPAP/BiPAP machine.

Please click the button below. for the staff to contact you back and recommend the next steps

(Brands other than Philips are not affected by this issue.)