PHILIPS VOLUNTARY RECALL

Aug 25th Latest news- Philips have said they are on track to replace machines late September or early October so make sure you register your machine. (I have registered all our clients, but your details may have changed)

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

 

 

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 

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

Picture1 PHILIPS CPAP machines.jpg

Eastern Clinic 8361 3698

Western Clinic 8353 6778

Southern Clinic 8125 0650

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About Sleep Clinics are leaders in the provision of diagnostic and treatment services for people in Adelaide with sleep disorders. Since 2006, the About Sleep Clinics have provided choices for people with sleep problems, delivered by qualified health professionals. Come in to see us, call us or send us an email, we will discuss your options and the process of gaining better sleep in a no obligation appointment.  Or phone Helen on 0436 141400 for general enquiries.

About Sleep Pty Ltd has affiliations with many therapies for sleep problems. We are authorised resellers for Resmed, Philips-Respironics, and Fisher and Paykel CPAP Therapy. About Sleep Pty Ltd also deal with Z1 and Transcend CPAP Machines. SomnoMed mandibular advancement splints, Re-Timer light Therapy and Lumin are added products we can advise you about and sell to you. We have discount prices and can often be the cheapest on-line as well.

Sleep Psychology is also available at our eastern and western clinics. Our fully trained Sleep Psychologist, Ms Marni Ahmer, has had extensive training at the Adelaide Institute of Sleep Health at Flinders Hospital

Airsense, Airmini, Dreamstation, Sleep Style and Z2 are all supported at our three clinics. Purchase from us and you have peace of mind that any problem can be sorted with a person, not an email.


 

About Sleep Eastern Clinic
240 Kensington Rd

Marryatville SA 5025

 

Ph (08) 8361 3698

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Ph (08) 8125 0650

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clinic@aboutsleep.com.au

 

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Monday - Friday 9am to 5.30pm

Saturday 9am to 12.00noon

Sunday and Public Holidays Closed

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