Product defect correction of Philips Sleep Apnoea devices

Philips, following consultation with the Therapeutic Goods Administration (TGA), is conducting an Urgent Product Defect Correction of the below mentioned Philips products.

As per TGA advice 6 July, patients are advised to not cease use of these devices without speaking to their physician or care provider. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified by Philips.

Patients will need to register their device on the Philips website here.

This will allow Philips to contact you to organise corrective actions or replacements.

We (National Pharmacies) work with a South Australian sleep company, CLM Sleep Co. to provide you with apnoea services including the supply of Philips products. Together, we have established an inhouse recall team dedicated to provide additional support and maintain a personalised service where possible.

If you have not already made contact with our recall team, please kindly email recall@clmsleep.com with your full name, contact number, and product serial number. You will then receive information on how to best proceed and have the opportunity to ask questions and address your concerns.

Product information

LEVEL: Consumer

CLASS: Class I

REFERENCE: RC-2021-RN-01373-1 DATE

AGREED: 1/07/2021

PRODUCT: Philips Respironics CPAP and Bi-Level PAP Devices

E30 (Emergency Use Authorization)

DreamStation ASV

DreamStation ST, AVAPS

SystemOne ASV4

C-Series ASV

C-Series S/T and AVAPS

OmniLab Advanced+

SystemOne (Q-Series)

DreamStation

DreamStation Go

All devices manufactured before 26 April 2021

ARTG’s: 133792, 209934, 235674, 257012, 257013, 295664, 285420, 327227, 335508

SHORT PROBLEM DESCRIPTION: Sound Abatement Foam – Susceptibility to Degradation and Volatile Organic Compound Emission