Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices
June 14, 2021
In consultation with the regulatory authorities, Philips is initiating a voluntary recall notification * to ensure patient safety
Corrective actions include providing updated instructions for use and a repair and replacement program for affected devices
Philips is committed to addressing all affected devices as part of this correction as soon as possible
Amsterdam, Netherlands – Follow the company To update on April 26th, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) today is providing an update on the recall notification * for certain Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilators to address identified potential health risks Relation to the soundproofing foam component based on polyester (PE-PUR) in these devices. The majority of affected devices within the recommended 5-year lifespan belong to the first generation DreamStation product family.
To date, Philips has manufactured millions of bi-level PAP, CPAP and mechanical ventilators using the PE-PUR soundproof foam. Despite a low rate of complaints (0.03% in 2020), tests have led Philips to determine that this type of foam poses potential risks to users. Risks include that the PE-PUR foam can break down into particles that can get into the airways of the device and be ingested or inhaled by the user, and the foam can outgas certain chemicals. Foam breakdown can be made worse by using unauthorized cleaning methods such as ozone **, and environments with high heat and high humidity can also contribute to foam breakdown.
For this reason, Philips has decided to voluntarily issue a recall notice * to inform patients and customers of the potential patient health and clinical application effects related to this issue and instructions on actions to be taken.
“We deeply regret any concern and inconvenience that patients using the affected devices may experience as a result of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips. “In consultation with the responsible supervisory authorities and in close cooperation with our customers and partners, we are working flat out on a solution that includes the provision of updated instructions for use and a comprehensive repair and replacement program for the devices concerned. Patient safety is at the heart of everything we do at Philips. “
Callback notification * Advice for patients and customers
The recall notification * advises patients and customers, based on the latest analysis of potential health risks and as a precaution, to:
For patients with affected BiLevel PAP and CPAP devices: Stop using your device and work with your doctor or long-life medical device (DME) provider to determine the most appropriate options for further treatment. If you want to continue using your device due to a lack of alternatives, contact your doctor to determine whether the benefits of continuing therapy with your device outweigh the risks identified in the recall notification. *
For patients with affected life support mechanical ventilators: Do not stop or change your prescribed therapy without talking to your doctor. Philips understands that for patients requiring a ventilator for life support therapy or in cases where interruption of therapy is unacceptable, alternative ventilation options for therapy may not exist or be severely limited. In these situations, and at the discretion of the treating clinical team, the benefits of continued use of these ventilators may outweigh the risks identified in the recall notice. *
Possible health risks
The company continues to monitor reports of potential safety issues under medical device regulations and laws in the markets in which it operates. To date, there have been no reports of deaths as a result of these problems. Philips has received reports of possible patient effects of the foam. Potential risks from particle exposure include headache, irritation, inflammation, breathing problems, and possible toxic and carcinogenic effects. Potential risks of chemical exposure due to outgassing include headache, irritation, hypersensitivity, nausea / vomiting, and possible toxic and carcinogenic effects. Philips has not received any reports of chemical emissions to patients.
Repair and exchange program
Philips will provide the relevant regulatory authorities with the necessary information regarding the introduction and implementation of the planned correction. The company will replace the previous soundproof foam with a new material and has already started preparations, including obtaining the relevant official permits. Philips is committed to addressing all affected devices as part of this correction as soon as possible.
As part of the program, the first generation DreamStation product families will be modified with a different soundproof foam and will be shipped upon receipt of the necessary regulatory approvals. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is unaffected by the issue. To support the program, Philips is increasing production of its DreamStation 2 CPAP machines, available in the US and select countries in Europe.
In terms of financial impact, Philips believes that the expected drop in sales of the Sleep and Ventilation businesses in 2021 will be offset by the strength of the company’s other businesses. Therefore, the forecast provided on April 26, 2021 for comparable revenue growth and the adjusted EBITA margin for the full year remain unchanged.
The updated instructions for use of the affected devices have led to an adaptation and acceleration of the repair and exchange program as well as intensified communication with customers and patients. This had resulted in an increase in the expected cost of corrective actions on an installed basis by € 250 million, on top of the provision the company recognized in the first quarter of 2021.
For more information on recall notification * and instructions for customers, users and clinicians, affected parties can contact or visit their local Philips representative www.philips.com/SRC-update.
* That is a Callback notification for the US only and a security notice for the rest of the world
** Potential Risks Associated with Using Ozone and UV Light Products to Clean CPAP Machines and Accessories: FDA safety notice.
For media and investor questions, please contact:
Philips Global Press Office
Tel .: +31 6 10888824
Philips Investor Relations
Tel .: +31 20 59 77222
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 lifestyles and prevention to diagnosis, treatment and home care. Philips leverages advanced technology and extensive clinical and consumer information to deliver integrated solutions. The company, headquartered in the Netherlands, is a leader in the areas of diagnostic imaging, image-guided therapy, patient monitoring and health informatics as well as in the areas of consumer health and home care. Philips achieved sales of 17.3 billion euros in 2020 and employs around 77,000 people in sales and Service in more than 100 countries. For news about Philips, go to www.philips.com/newscenter.
This press release contains certain forward-looking statements regarding the financial condition, results of operations and business of Philips and certain plans and objectives of Philips with respect to such items. Examples of forward-looking statements include statements regarding strategy, estimates of sales growth, future EBITA, the future development of Philips’ organic business and the completion of acquisitions and divestments. By their very nature, these statements involve risks and uncertainties, as they relate to future events and circumstances and there are many factors that could mean that actual results and developments differ materially from those expressed or implied in these statements.