Philips provides update on completed set of test results for first-generation DreamStation sleep therapy devices

December 21, 2022

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG; AEX: PHIA) today provides an update on the comprehensive test and research program of its subsidiary Philips Respironics, following the voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices.

Following previous updates in December 2021 and June 2022, additional test results and assessments have now been completed for the first-generation DreamStation devices (approximately 68% of the registered devices globally). These devices have not been exposed to ozone cleaning in line with the instructions for use.

The test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.

The full press release is available in the attached PDF and available here.

* Voluntary recall notification in the US/field safety notice for the rest of the world.

For media questions, please contact:

Steve Klink
Philips Global Press Office
Tel.: +31 6 10888824
E-mail: steve.klink@philips.com

Ben Zwirs
Philips Global Press Office
Tel.: +31 6 15213446
E-mail: ben.zwirs@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, 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 2021 sales of EUR 17.2 billion and employs approximately 79,000 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 statement 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.

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China denies report it is developing reefs and cays in the South China Sea

China has dismissed a report that Beijing has been developing at least four unoccupied features in the South China Sea. Some U.S. experts have also casted doubt on the claims.

A Bloomberg News report on Tuesday quoted unnamed Western officials as saying China is building up several unoccupied land features including Eldad Reef, Lankiam Cay, Whitsun Reef and Sandy Cay, all in the Spratly archipelago, also claimed by the Philippines, Vietnam and Taiwan.

China rejected the news, with the South China Sea Probing Initiative (SCSPI) think tank calling it “100% fake news.”

Beijing has already developed several artificial islands in the disputed South China Sea and fully militarized at least three of them with airfields, radars and hangars, but this new revelation may be “the first known instances of a nation doing so on territory it doesn’t already occupy,” reported Bloomberg.

The officials, who asked not to be identified so they could discuss sensitive information, told the news agency that “some sandbars and other formations in the area expanded more than ten times in size in recent years.”

The previously submerged features have now been exposed and reinforced to “sit permanently above the high-tide line,” according to the officials.

If true, this would be a major step towards changing the status quo in the South China Sea by Beijing, which claims “historical rights” to almost 90% of the sea as well as the islands and other land features inside it.

Brunei, Malaysia, the Philippines, Vietnam and Taiwan also claim parts of the resource-rich sea.

Land formations

A UN tribunal in 2016 ruled that China’s claims in the South China Sea have no legal basis but Beijing has so far rejected the ruling.

China has developed at least seven artificial islands in the South China Sea, creating 3,200 acres (1,295 hectares) of new land since 2013, according to the Asia Maritime Transparency Initiative (AMTI) at the Washington-based Center for Strategic and International Studies.

U.S. Indo-Pacific commander Adm. John C. Aquilino said in March that three of them – Mischief Reef, Subi Reef and Fiery Cross – appeared to be fully militarized and equipped with missile systems and fighter jets.

The AMTI, which keeps a close eye on developments in the South China Sea, has yet to report on any new activities by China.

“China has not occupied a new feature since December 1994 and has not built up anything it didn’t already occupy,” said AMTI director Greg Poling.

Poling said “commercial imagery cannot corroborate” the claims made in the Bloomberg report.

“All I can say for sure is that the sandbars at those four features have shifted over time but have on average been the same size. If there is evidence of construction, it must be very subtle and it must not be visible in commercial satellite imagery,” he told RFA.

Another expert, Taylor Fravel at the Massachusetts Institute of Technology, pointed out that landforms appear and disappear in the South China Sea.

A report on Eldad Reef by the Center for International Law at the National University of Singapore (NUS) said “sand banks are dynamic and change location, size and shape under the combined effect of astronomic tides, storm surges and wind-waves.”

Eldad.jpg
Eldad Reef is a coral reef platform located at Tizard Bank in the South China Sea. CREDIT: NASA

Dredging marks

Eldad Reef is a coral reef platform located at Tizard Bank in the northwestern part of the Spratly Islands. 

China calls it Anda Jiao and Chinese vessels have reportedly been carrying out some dredging at the reef since 2014, as well as harvesting endangered giant clams, according to Philippine media which call it Malvar Reef.

The report by the NUS also said “dredging marks are visible on several sandy parts of the reef, totalling a surface area of 1.35 square meters [14.53 square feet].”

It is understood there has not been a large-scale reclamation of, or a man-made structure on, Eldad. The unoccupied reef is claimed by China, the Philippines, Taiwan, and Vietnam which calls it Da En Dat.

The Beijing-based SCSPI, responding to the Bloomberg report, said there are “no signs of land reclamation on Lankiam Cay,Eldad Reef and Whitsun Reef.”

Whitsun Reef, known as Julian Felipe Reef in the Phillipines, lies inside the Philippines exclusive economic zone, about 175 nautical miles (324 kilometres) west of the country. 

Hundreds of Chinese vessels were “persistently swarming” the waters around the reef in March and April this year, prompting Manila to lodge several diplomatic protests.

Increased tensions in the South China Sea also led to another claimant, Vietnam, building up its outposts. Hanoi has created 520 acres (210 hectares) of new land in the Spratlys in the last ten years, 80% of which were reclaimed in 2022 alone, according to AMTI.

Vietnam’s total reclamation area to date is still less than 20% of China’s.