Notice
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Affecting Philips Respironics CPAP, BIPAP, and Ventilator devices
On June 14, Philips Respironics issued a voluntary product recall for its breathing devices and ventilators due to sound abatement foam that has a potential to break down and be inhaled. The recall involves only specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices, and Mechanical Ventilators. According to Philips Respironics, the foam breakdown may be worsened by ozone related cleaning methods. The potential risk of degraded foam exposure are listed on the manufacturer's website. Philips Respironics has reported no significant harm to patients at this time. Affected device models are linked here.
What should patients do in response to this alert?
At this time, there is no significant harm to patients reported by Philips Respironics and the rate of customer complaints has been low. We recognize for many patients, abrupt discontinuation of these devices may be a greater risk to their health than continuing to use them.
For that reason, we offer the following guidance:
For patients using life-sustaining mechanical ventilator devices, we recommend patients do not stop or alter prescribed therapy until after talking with your ordering provider.
For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties or have significant pulmonary, cardiovascular or neurologic comorbidity, or were very sleepy during the daytime before treatment, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that patients do not stop prescribed therapy until first discussing with their provider.
Some patients may safely be able to stop using their device for a period of time. Patients with mild forms of sleep disordered breathing, who do not have other major health problems or significant sleepiness may elect to discontinue using their device as recommended by Philips, but should contact their ordering provider if they are not comfortable doing so, or wish to discuss management options.
If the patient is using ozone or ultraviolet light products for cleaning their device or accessories, we recommend they stop immediately. Use hot, soapy water only.
If the patient notices any black debris/particles within the airpath circuit, the patient should contact their ordering provider.
Patients are advised to review all of the information regarding this recall and register their device on the following website: www.philips.com/src-update. Patients can call Philips at (877) 907-7508 for additional support and help with registration of their device.
Please note, the information and guidance provided will be updated as further details on the recall become available.
Who should the patient contact with questions?
Patients should speak with the ordering provider, their direct primary care provider, or durable medical equipment supplier.
Where can the patient receive more information?
Patients are advised to review all of the information regarding this recall and register their device on the following website: www.philips.com/src-update.
The information contained in this notice was provided primarily by the device manufacturer and may not have been independently verified by UW Health. This information is subject to change as new information is provided by the manufacturer.
Where can I read additional questions and answers from Philips Respironics?
Visit the Philips recall FAQ here
Information for pediatric patients
My child is ventilated through a tracheostomy tube by an affected Trilogy or A-series BiPAP. What should I do?
Children who receive ventilation through a tracheostomy tube should continue to use their device as prescribed. In the meantime, you should:
Continue to use an inline bacterial filter.
Register your child’s device on the recall website or call (877) 907-7508 for assistance.
Contact your Durable Medical Equipment representative regarding next steps for obtaining a replacement device.
Do not use unapproved cleaning methods, especially those that contain ozone.
Read the official recall notice here (pages 1-2)
Contact your child’s pulmonary or sleep medicine provider with any additional questions or concerns.
My child receives ventilation by a mask (non-invasively) by an affected Trilogy or A-series BiPAP. What should I do?
Children who receive ventilation non-invasively through these devices should continue to use their device as prescribed. In the meantime, you should:
Continue to use an inline bacterial filter.
Register your device on the recall website or call (877) 907-7508 for assistance.
Contact your Durable Medical Equipment representative regarding next steps for obtaining a replacement device.
Do not use unapproved cleaning methods, especially those that contain ozone.
Read the official recall notice here (pages 1-2)
My child receives PAP therapy by a mask (non-invasively) by an affected CPAP or Bi-Level PAP Device. What should I do?
In general, most children who receiving Positive Airway Pressure (PAP) therapy should continue to use their device as prescribed.
If your child only has mild obstructive sleep apnea, and you have questions regarding if continued use outweighs potential risks, contact your child’s pulmonary or sleep medicine provider. In the meantime, please do the following:
Register your child’s device on the recall website or call (877) 907-7508 for assistance.
Contact your Durable Medical Equipment representative regarding next steps for obtaining a replacement device.
Do not use unapproved cleaning methods, especially those that contain ozone.
Read the formal recall notice here (pages 3-4)
