Voluntary Recall Information
Philips Respironics Sleep and Respiratory Care devices
In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).
Approximately 2,800,000 new devices and repair kits produced to meet the U.S. registration demand*
Approximately 2,300,000 devices remediated and in the hands of U.S. patients and Durable Medical Equipment providers (DMEs)**
** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Repair kits are utilized in the rework process to create a recertified unit. To learn more, click here.
Patient safety is our top priority.
We are committed to completing the remediation of all registered devices and have substantially increased the production of replacement devices.
With devices ready for patients, we are asking customers and clinicians to help get these devices to those who need them by reminding patients that they may need to take specific action in the Patient Portal to receive their replacement device.
It is important that patients feel confident using their devices. Since the recall, we’ve carried out a test and research program to learn more about the polyester-based polyurethane (PE-PUR) sound abatement foam, working with independent laboratories and third party experts and physicians. The latest results of the testing and analysis we have done over the past 18 months can be found here.
We know there is still more to be done. As we continue to work through the voluntary recall, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete recall efforts.
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.
Not yet registered?
May 2023 update on completed testing for home sleep therapy devices shows no appreciable harm to patients
The tests, conducted together with five independent, certified testing laboratories and assessed by third- party qualified experts and Philips Respironics, as well as an external panel of experts, have now been completed and risk assessments evaluated for all home sleep therapy devices.
Questions and answers
E30
(Emergency Use Authorization)
DreamStation ASV
Also known as DreamStation BiPAP autoSV
DreamStation ST, AVAPS
Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T
SystemOne ASV4
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
C Series S/T, AVAPS
Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
OmniLab Advanced Plus
In-Lab Titration Device
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30
Also known as BiPAP Hybrid A30Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP V30 Auto Ventilator
Also known as BiPAP V30 Auto Ventilator (A-Series)
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40
Also known as BiPAP A40 Ventilator (A-Series)
(not marketed in US)
A-Series BiPAP A30
Also known as BiPAP A30 Ventilator (A-Series)
(not marketed in US)
If your device is affected...
What products are not affected and why?
Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.
Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world.
