Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

This Product recall is part of the Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators collection. Visit the collection to see further progress updates.

3 January 2024

The recall action for the sleep apnoea and respiratory care machines is nearing a close with the majority of devices having now been replaced or refunded.

Philips continues to provide updates to us on the testing they have done on the sound-abatement foam in the devices and routinely update their website. The latest update 
from Philips on the tests carried out on these devices can be found at the news on the Philips website. 

It is noted in the latest information supplied by Philips that a correction has been made to the list of volatile organic compounds (VOC) potentially affecting users of the devices. The original list included dimethyl diazene but this is incorrect and the compound has now been confirmed as acetone.

This correction does not change the regulatory action taken in Australia. 

A reminder - if you use a Philips Continuous Positive Airway Pressure (CPAP) or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine and you have not yet registered with Philips to obtain a replacement device or refund, please register as soon as possible on the Philips website. 

8 July 2022

Mid-year progress update

Over 60% of the affected devices registered with Philips in Australia have now been corrected under the repair/replacement program.

There have been some delays to devices being corrected. This is due to a variety of reasons, some of which are beyond Philips' control. We are working with Philips to minimise these delays where possible.

Despite the delays, Australian patients are receiving their corrected devices ahead of many global markets.

BiPAP settings (patient script) issues

Some patients have received replacement BiPAP devices with settings (patient scripts) that have been incorrectly installed by Philips.

If you are experiencing any discomfort or your therapy does not seem to be effective, you need to have your therapy settings checked by either:

1. Contacting Philips on 1800 009 579 or
2. Contacting your sleep clinician.

Your BiPAP device has two types of settings:

• "Therapy setting" (patient script) which you cannot change. This must be done by Philips or your sleep clinician and
• "Comfort setting" which you are able to adjust to suit your individual needs by using the "My Settings" menu on your device.

Some patients who have received replacement BiPAP devices with incorrect script settings have been contacted by Philips and their devices have been fixed. Philips will be writing to all patients and working to ensure that all BiPAP device settings have been correctly installed.

If you are feeling unwell, please seek medical attention.

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

Updates on repair / replacement program

Repair / replacement for all affected devices has commenced, except for:

• A Series BiPAP
• Omnilab and
• DreamStation Go devices.

For a full list of impacted devices please refer to the table below (25 June 2021 update).

The TGA has taken regulatory action and fined Philips for the delay in providing important information. Philips are now required to meet weekly with the TGA to ensure that progress with the remediation plan remains on track and any further delays to the repair/replacement program are identified as soon as possible.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Device repair/replacement program - progress update

16 December 2021

Approximately 20% of the affected devices registered with Philips in Australia for correction have now been corrected under the repair/replacement program. Users are reminded that registration at https://www.philipssrcupdate.expertinquiry.com is vital to ensure you receive the repair or replacement of your device.

In addition to the DreamStation CPAP and 50 Series CPAP, the repair/replacement program for DreamStation BiPAP devices has now also commenced. Philips has advised the repair/replacement for the following devices will also commence in December 2021-January 2022:

• DreamStation ASV
• DreamStation ST, AVAPS
• 50 Series ASV
• C Series ASV (60 Series)
• C Series S/T AVAPS (60 Series)

If you require assistance to set up your replacement device please contact Philips at 1800 830 517 (Option 1). If required, Philips may arrange an in-clinic assessment to assist you.

You can verify that your device no longer has the impacted PE-PUR foam by checking the label for a 'UDI' field which is being included on all repaired devices (as shown in the before / after label pictures below):

The label is found on the bottom of your device (or on the back of the Trilogy 100 devices).

In the event you have an upcoming surgical procedure and have not received a repaired or replaced device, please advise your clinician prior to your procedure (as early as possible) that you use an affected device and speak with them about ongoing use following surgery.

Updates on the supply of CPAP, Bi-Level PAP devices and mechanical ventilators

Philips are currently working to manufacture enough devices for users affected by the issues with PE-PUR foam. Given this, they are unable to fulfil orders at this time for new patients requiring CPAP or Bi-Level PAP devices.

Supply of Trilogy Evo ventilators has resumed for new patients requiring ventilation, noting this model supersedes the Trilogy 100 model.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Device repair/replacement program has commenced

18 November 2021

The repair/replacement program for the following Philips' devices commenced on 3 November 2021:

• DreamStation CPAP
• 50 series CPAP

Registered users are being contacted by Philips to confirm their details in the lead up to each device being corrected.

If you have received your replacement device and need assistance to set it up, visit the Philips website for support.

We will provide updates as the program progresses to include other models.

If your contact details have changed since you registered your device, please notify Philips on 1800 009 579.

US-FDA inspection of Philips Respironics Inc

The US-FDA has recently published an update to their report on inspections of a Philips Respironics Inc manufacturing facility. The report outlines concerns with the risk identification process used to identify models subject to recall actions. There was also a question raised about the silicone-based sound abatement foam being used as a replacement for the PE-PUR foam.

Until further findings become available, the US-FDA have not advised of any change to the replacement program in the USA and Philips are continuing their repair and replacement program in Australia. Patients who have already had the PE-PUR foam replaced should continue use of their device, unless instructed otherwise by their doctor.

The TGA is working closely with international regulatory agencies, including the US-FDA, to ensure a consistent global approach to the identified safety concerns.

Recommendations for users with devices that have not yet been corrected remain unchanged.

We will provide further updates on this matter as new information becomes available.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Consumer and regulatory updates

23 September 2021

The TGA has heard from many people affected by this action. We appreciate your feedback and recognise the seriousness of your concerns. Hearing from you assists us in our discussions with Philips to ensure the effectiveness of their proposed actions.

How long will it take for my device to be repaired? Can TGA speed this up?

What is the TGA's role in a recall action and what has TGA done for this issue?

Why is this a 'product defect correction' rather than a 'recall'?

Are other devices impacted by this issue?

Can I use an inline filter with my device?

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Consumer and regulatory updates

18 August 2021

The TGA continues to receive enquiries from consumers concerned about progress with this recall action. Please see the following information we have provided on common questions.

How are users being notified of the sound abatement foam issues?

Does the replacement process require regulatory approval in Australia?

What is the current timeframe for my devices to be fixed or replaced?

I have already purchased a new device, what should I do?

I would like a refund or reimbursement

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Update - further information for consumers

16 July 2021

If you have not already done so, please register your device at www.philips.com/src-update. This information is needed so the company can plan the repair/replacement program efficiently.

Some consumers have reported that they are not sure if their registration has been received. When you register you will get a registration number. If you don't receive this number, please re-register your device. To help reduce this confusion, Philips is now sending a confirmation email with each new registration.

Other consumers have purchased their device overseas and are not sure if they should register here. If you currently live in Australia, regardless of the place of purchase, go to the Philips registration website and select 'Australia' before entering your serial number.

Towards the end of this month, Philips will begin contacting everyone who has registered their device. They will confirm your details and outline the type of correction proposed for your device. This may take some time given the large number of affected people. Depending on the device type and its age, Philips will either provide a new base unit device or replace the foam component.

We will continue to update you as further information becomes available.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Update - Product defect correction

9 July 2021

The TGA is aware that some consumers are having difficulty contacting Philips about the safety concerns with their devices. The company has advised us that additional resources are being put in place to help with the high level of calls.

It is important that customers register their devices on the Philips website. This will help us plan an effective approach to either repair or replace them, taking into account the specific needs of various patient groups. Some additional guidance on registering is outlined below.

We will publish further information on repair and replacement timeframes as soon as this is available. The TGA is assessing safety information to ensure any proposed actions are appropriate - these may be different for different devices. Philips has confirmed that replacing the device or replacing the foam will be done at no cost to the patient.

It is strongly recommended that you do not attempt to remove the foam yourself and then continue using your device. Discuss your concerns with your health professional and register your device on the Philips website.

Information for consumers

You need to register your device on the Philips support website. Please follow these steps:

1. Go to www.philips.com/src-update and click on "Begin registration process"

   (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process")

2. Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas)
3. Continue to follow the remaining steps, ensuring you enter your device's Serial Number to check if your device is affected
4. If your device is affected, you will be asked to register your device.

Experiencing problems

If you are experiencing any of the symptoms listed below, talk with your health professional. We also encourage consumers and health professionals to report problems with medical devices to the TGA.

We will publish further updates as new information becomes available, to continue providing support for all users, health professionals and customers impacted by this issue.

If you have any questions or concerns, contact Philips Electronics Australia Ltd on 1800 009 579. Further information is available at www.philips.com/src-update.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Product defect correction - safety hazard caused by foam degradation and emissions

6 July 2021

Philips Electronics Australia Ltd, following consultation with the TGA, is undertaking a product defect correction for the 14 sleep and respiratory care devices identified in the tables below. This is in response to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these goods.

Philips has identified that the foam used in the blower boxes of their continuous and non-continuous ventilators may degrade into particles, which may enter the devices' air pathway and be ingested or inhaled by the user, and release certain chemicals as gases. The foam may degrade more quickly if the device is cleaned using unapproved cleaning methods, such as ozone gas products.

Where possible, Philips will replace the sound abatement foam in affected devices. If this is not possible, a replacement device will be provided.

Information for consumers

Check the list of devices lower on this page to see if your device is affected by this action.

Do not stop using your device without speaking to your physician or care provider. Stopping treatment suddenly could have an immediate and detrimental effect on your health.

You need to register your device on the Philips support website: www.philips.com/src-update. This will allow Philips to contact you to organise the corrective actions or a replacement device.

If you have any questions or concerns, contact Philips Electronics Australia Ltd on 1800 009 579. Further information is available at www.philips.com/src-update.

If your device is an affected CPAP or bi-Level PAP unit

Please make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.

Please ensure you follow the recommended cleaning and replacement guidelines in the operating manual for your CPAP machine and accessories.

If your device is an affected mechanical ventilator

Do not stop or alter your prescribed ventilator therapy.

Please make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.

You can use an inline bacterial filter to help reduce the risk of inhaling particles of foam. These filters will not reduce exposure to the gases that may be released by the degrading foam.

Guidance on installation of the filter is found in the device's operating manual. It is important to install these correctly as a filter may increase the resistance of air flow.

Information for health professionals

Please be aware of the safety concerns associated with these devices and advise patients accordingly. A patient-specific risk assessment may be needed to determine whether the benefits of continuing therapy outweighs the risks identified.

If you have any questions or concerns about this issue, please contact Philips Electronics Australia Ltd support hotline on 1800 009 579. Further information is available at www.philips.com/src-update.

Risk assessment outcomes

Philips' investigations identified that the majority of particles are of a size unable to penetrate into deep lung tissue and are likely to remain in the patient's upper airway. Only particles with a diameter of <1-3 μm may penetrate into the lower respiratory tract.

Analysis of the degraded foam demonstrates the particles may include compounds such as diethylene glycol (DEG), toluene diamine isomers (TDA) and toluene diisocyanate isomers (TDI). Philips is undertaking investigations to assess whether the amount of degraded PE-PUR foam inhaled and/or ingested by a patient may potentially exceed the tolerable intake for these compounds.

The foam may also emit certain chemicals (volatile organic compounds - VOCs). Product testing has shown that this 'off-gassing' mostly occurs during initial operation, but may possibly continue throughout the device's useful life. 

The potential risks associated with these issues include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), inflammatory responses, asthma, hypersensitivity, nausea / vomiting, adverse effects to other organs (e.g. kidneys and liver) and possible carcinogenic effects.

The complaint rate associated with these issues was 0.03% for the year 2020. To date, there is no definitive evidence of long-term harm to patients and there have been no reports of death.

Update - Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Safety hazard caused by foam degradation and emissions

25 June 2021

The TGA is now able to confirm that the following devices are affected by this action.

If your device is an affected mechanical ventilator, use of an inline filter will reduce the risk of inhaling particles of foam. Guidance on installation of the filter is found in the device's Instructions for Use document (or 'operating manual').

We re-iterate our earlier advice that, in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available. Patients should speak with their health professional prior to making any changes to their prescribed therapy.

Where possible, affected devices will have the sound abatement foam component replaced. Information on the timing of this correction is still being confirmed with Philips.

We will publish further information as soon as it becomes available, including advice that the recall action has commenced in Australia and the outcomes of TGA's risk assessment.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Safety hazard caused by foam degradation and emissions

18 June 2021

The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

The majority of the affected devices are in the first-generation DreamStation product family.

A full risk assessment is underway including numbers supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers.

As a precautionary measure, pharmacies are advised to quarantine and remove from sale any unsold units of the affected devices.

We will continue to work with Phillips to ensure that comprehensive information is made available as quickly as possible through formal published announcements on the TGA website and from Phillips directly to customers.

Information for consumers

For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.