Philips Respironics Australia and New Zealand Update 2023
22 September 2023 - Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand) -
Philips Respironics Australia and New Zealand
For further information about the steps Phillips Respironics are taking to ensure the safety of your CPAP and BiPAP machines, please click here.
The Therapeutic Goods of Australia (TGA) is also working closely with Phillips Respironics to ensure that information about the DreamStation product family are being communicated to customers. Please click here for more information.
15 June 2021 - Medical Device Recall - Philips Respironics Australia and New Zealand
Philips has advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. View the full list of devices here.
The following information has been provided by Philips:
On June 14, 2021, the company at a global level voluntarily decided to issue a recall notification for specific affected devices.
The recall notification informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. In Australia and New Zealand, the local Philips entities (Philips ANZ) are currently engaging with the local regulatory bodies in relation to the recall action for Australia and New Zealand. Philips ANZ expects the recall action to commence in Australia and New Zealand soon.
Information about the recall action will be communicated by letter and website and where possible patients and customers will be contacted directly. This will include a recall notification that will be localised for Australian and New Zealand patients and customers.
In the meantime, globally Philips has advised patients and customers to take the following actions:
For patients using life-sustaining mechanical ventilator devices:
- Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
- If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.
For patients using BiLevel PAP and CPAP devices:
- Discontinue use of your device and work with your physician to determine the most appropriate options for continued treatment.
If you have any questions regarding this update, we encourage you to visit Philips’ website which includes a detailed FAQ section.
Blooms The Chemist continues to work closely with Philips to provide our customers with as much information as possible and will share further updates in the coming days.
Previous Update
30 April 2021
Philips has provided an important update regarding proactive efforts to address identified issues with a component in certain products of their Sleep & Respiratory Care portfolio.
Philips has determined from user reports and testing that sound abatement foam used in a number of Philips sleep and respiratory care devices may degrade under certain circumstances.
This occurrence may be influenced by factors including use of unapproved cleaning methods such as ozone, environmental conditions involving high humidity and temperature, and age of device.
To date, Philips has not received reports of serious patient harm related to this issue.
For more information, please visit here.