Sep 02, 2021

Philips Singapore provides update to Field Safety Notice related to certain devices in its sleep and respiratory portfolio

Singapore – Philips Singapore today provides an update on the local corrective action related to the Field Safety Notice for specific sleep and respiratory care devices, which was issued to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

Following the company’s global announcement, Philips notified the Health Sciences Authority of Singapore and subsequently issued a Field Safety Notice to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.

Philips began communication on the Field Safety Notice in Singapore by requesting that authorised distributors notify their patients and held information seminars with physicians. The company has also issued updates on their local website: www.philips.com/src-update which includes advice and instructions for patients, customers, distributors and physicians.

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 Singapore is underway, with initial supply of new material for DreamStation devices currently expected from about late September [1], with other devices following thereafter. Philips aims to address all affected devices within the scope of this correction. Due to the volume of devices, we regret it may take some time to repair or replace patients devices.

Registration is a necessary step patients need to complete through their authorised distributors to enable Philips to organise the repair and/or replacement of their devices. If patients or customers have any questions or concerns, including how to register, a dedicated Philips customer care team is set up to receive and address all inquiries and to advise on next steps 1800-28-63-020, 9am-6pm (Mon-Fri).

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

For more information on the status of the field safety notice as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

We cannot stress enough that Philips is treating this matter with the highest level of seriousness and is dedicating significant time and resources to address this issue. Our intention is to give affected patients and customers the service they expect and deserve as we work to resolve this matter as our top priority.

[1] Subject to delays due to pandemic related logistics disruption

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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