PHILIPS VOLUNTARY RECALL

Dec 14th 2021 - Philips are sending out some new Dreamstations to people who have purchased a DS in the last 2-3 years. If you would prefer a new Resmed machine please contact me for information.- helen@aboutsleep.com.au. This includes all people with any Philips machine listed below,

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Philips Healthcare have put out a voluntary recall of all their CPAP and Bi-level machines. They make the 50 and 60 series, and the Dreamstation and Dreamstation Go CPAP machines. Several other Philips machines are also listed - see the link below.  Australia’s Therapeutic Goods of Administration is working with Philips on managing this due to the risks to Australians posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

 

The TGA have said ”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.

If your device is an affected mechanical ventilator, use of an inline filter will reduce the risk of inhaling particles of foam.”

 

The filters must be used without a humidifier, and they will last 1-2 months. They will not work with a humidifier as the water degrades the filter. Depending on which mask and tubing you have, you may need a different tubing (non-heated) so the filter can sit near the machine, not near your face or the top of your head. We have these filters available in all our clinics.

 

The only machines involved that we have sold are Dreamstations, Dreamstation Go, Philips Respironics PR 60 series and Respironics 50 series – photos below. Remstar, System One, CFlex and AFlex are also words found on these machines only

 

 

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Consumers are encouraged to report problems with medical devices to the TGA. Your report will contribute to the TGA’s monitoring of these products. If you have a health problem, seek advice from a health professional as soon as possible. Reporting can be done online, or by email at iris@health.gov.au. The phone number is 1800 809 361 during business hours.

 

Resmed and Fisher and Paykel machines are not involved in this recall. No CPAP mask or tubing is subject to this recall. Philips masks and tubings can continue to be used.

 

Please email me for further advice. If you would like to purchase a filter, please email me with possible times and I will book you in. When you come in, please bring your machine and mask so we can show you where to put the filter. At this stage, Philips do not have a website for you to register your device. I will email you ASAP when this opens in Australia.

 

My sincere apologies for this notification,

Kind regards,

Helen Gilbert 

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Link to  Australian TGA recall notice Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators | Therapeutic Goods Administration (TGA)

Link to Worldwide Recall  - Sleep and respiratory care update | Philips

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