Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification*
Royal Philips (NYSE: PHG) has announced an update regarding the recall of specific sleep and respiratory care devices due to potential health risks from a foam component. Most affected units are in the U.S., with over 80% being first-generation DreamStation devices. The FDA has authorized the rework of these devices to replace the problematic foam, with repairs expected to start in September 2021. Philips aims to complete this process within 12 months and has initiated replacement programs in other countries, enhancing production and outreach to affected patients.
- FDA authorized the rework of affected DreamStation devices to replace the PE-PUR foam.
- Philips is initiating repair and replacement programs globally, starting in September 2021.
- The company is increasing production and service capacity to expedite remediation efforts.
- Over 80% of affected devices in the U.S. are from the first-generation DreamStation family, indicating a significant recall scale.
- The remediation process for affected devices is expected to take around 12 months, causing potential disruptions for patients.
September 1, 2021
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG; AEX: PHIA) today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the US. The vast majority (>
Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US [2].
Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.
“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” said Frans van Houten, CEO of Royal Philips. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”
More information on the recall notification, as well as instructions for customers, users, and physicians can be found at www.philips.com/src-update. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program.
* This is a recall notification for the US only, and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall.
[1] This includes DreamStation CPAP, Auto CPAP; Dream Station Bi-Level PAP; DreamStation ASV; and DreamStation ST, AVAPS devices.
[2] The remaining affected devices for remediation in the US can be found at www.philips.com/src-update.
For media information, please contact:
Ben Zwirs
Philips Global Press Office
Tel.: +31 6 15213446
E-mail: ben.zwirs@philips.com
Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: derya.guzel@philips.com
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.
Forward-looking statements
This release contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips’ organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.
FAQ
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