News center | Australia

Sep 01, 2021

Philips Australia provides update to the Urgent Product Defect Correction related to certain devices in its sleep and respiratory portfolio 

   

Sydney, Australia – Philips Australia today provides an update on the local corrective action related to the urgent product defect correction authorised by the Therapeutic Goods Administration (TGA) for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices, which addressed identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

Following its local company announcement, Philips began communication on the Urgent Product Defect Correction Notice which includes direct customer letters, mass print and online media, as well as updates on the company’s local website: www.philips.com/src-update. Where patients are not directly managed by Philips, the company has also requested that care providers also contact their direct patients.

 

Philips has mobilised the necessary resources across the company to address the component quality issue. The priority is to replace the foam with the new material in all the affected devices either by repairing or replacing with like devices. The company’s efforts include wide-scale, global ramping up of manufacturing, repair, services, and supply chain to support this corrective action.

 

Repair and replacement program

 

The repair and replacement plan in Australia is underway, with an initial delivery of replacement DreamStation devices expected to be sent by the manufacturer to Australia in late September. Philips will be contacting registered patients and customers with the relevant information on the next steps to implement this corrective action.

 

Philips aims to address all affected devices within the scope of this correction but due to the volume of devices and different models that have been affected, we regret it may take some time to repair or replace patients' devices. Philips will provide further updates on the repair and replacement plan, including for other affected models.

 

The registration process that Philips has established allows patients, users, or caregivers to look up their device serial number and begin registration if their unit is affected. Registration is the initial important step that patients need to complete to enable the company to organise the repair and/or replacement process for patients. Philips kindly requests that patients visit the website to register their devices: www.philips.com/SRC-update

 

Philips notes that consumer law rights under the Australian Consumer Law and the New Zealand Consumer Guarantees Act are in addition to any remedy that the company may provide.

 

Philips continues to advise patients to consult with their treating physician or care provider to determine the most appropriate options for continued treatment.

 

Additional information

 

Philips is also working on the repair and/or replacement process for New Zealand.

 

A dedicated customer care team is set up to receive and address patient inquiries and concerns (1800 009 579 in Australia or 0800 578 297 in New Zealand – toll free). For more information on the status of the product defect correction as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

 

In addition to the company’s website, Philips urges all patients and their caregivers to use reputable sources such as the TGA website for accurate and up to date information on this matter.

 

Philips is treating this matter with the highest level of seriousness and regrets the inconvenience this is causing our patients and customers. Philips is absolutely committed to supporting the community of patients who rely on its Sleep & Respiratory Care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Contacts

Albertine Schor

Sarah Al-Hashimi

Corporate Communications Manager

Philips, Australia & New Zealand

E-mail: sarah.al-hashimi@philips.com

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