Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification*

November 14, 2021

Amsterdam, the Netherlands – On June 14, 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the US and several other markets is under way.

As expected, the US Food and Drug Administration (FDA) recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. On November 12, 2021, the FDA published a list of the observations it provided to Philips Respironics. In accordance with normal practice, Philips Respironics will submit its response to the inspectional findings for review by the FDA. Importantly, an FDA investigator’s list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. Additionally, the FDA has not changed its recommendation to patients and healthcare providers in relation to affected devices.

“In connection with the voluntary recall notification in June of this year, the FDA has recently conducted an inspection of a Philips Respironics manufacturing facility in the US,” said Frans van Houten, CEO of Royal Philips. “We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing. Until we have concluded these discussions, we are not able to publicly provide further details on these responses. We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.”

Since June 2021, Philips Respironics and certified testing laboratories have been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, with support from appropriately qualified third-party experts. Philips Respironics plans to make more data available to the relevant competent authorities as soon as possible after completing the assessment of the above mentioned research and tests, which is anticipated to take place in the fourth quarter.

Separately, Philips Respironics has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated acceptable results. Philips Respironics continues to coordinate with the FDA and other competent authorities on its testing.

An FAQ is available here.

* Voluntary recall notification in the US/field safety notice outside the US

For further information, please contact:

Steve Klink
Philips Global Press Office
Tel.: +31 6 10888824
E-mail: steve.klink@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 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 2020 sales of EUR 17.3 billion and employs approximately 78,000 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.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

One Killed, Four Wounded As Explosion Hits Bus In Kabul

KABUL– At least one civilian was killed and four others wounded, when an explosion struck a bus on a busy road, in the western part of Afghanistan’s capital, Kabul, yesterday, according to multiple sources.

“We heard a huge blast in the minibus, carrying commuters in Mahtab Qala locality of Dashti Bari area. The whole place has now been sealed off by the security forces,” an eyewitness said.

The vehicle caught fire, sending a column of thick smoke into the sky and triggering panic, the witness said.

A source from Hakim Nasir Khesrow Balkhi Hospital, located in Police District 18 of the city, where the explosion occurred, told local reporters that, one civilian was killed and four other people, including a woman, were wounded in the blast.

Taliban spokesman, Zabihullah Mujahid, confirmed the incident on Twitter, saying that, an investigation has been launched and details will be shared with the media at an early time.

No group has claimed responsibility for the attack yet.

Kabul witnessed a series of terror attacks staged by militants, affiliated with the Daesh, against the Afghan caretaker government, since Taliban’s takeover of the country in mid-Aug.

Source: NAM NEWS NETWORK

US, China Trade Taiwan Warnings Ahead of Biden-Xi Meeting

The top diplomats from China and the United States have exchanged stern warnings over the flashpoint issue of Taiwan, ahead of Monday’s hotly awaited meeting between their leaders.

The virtual meeting of presidents Joe Biden and Xi Jinping comes against a backdrop of rising tensions — in part over Taiwan, a self-ruling democracy claimed by Beijing, but also over trade, human rights and other issues.

In a phone call Friday with Chinese Foreign Minister Wang Yi to discuss preparations for the meeting, U.S. Secretary of State Antony Blinken raised concerns over Beijing’s “military, diplomatic, and economic pressure” on Taiwan.

Wang warned of the dangers of US actions that might seem supportive of “Taiwan independence.”

Washington switched diplomatic recognition from Taipei to Beijing in 1979, but an act of Congress passed that year requires the United States to provide weapons to Taiwan for self-defense.

The U.S. government is careful not to show it recognizes Taiwan but it enjoys broad, bipartisan support in Congress, with a group of lawmakers visiting the island this month — angering Beijing.

“Any connivance of and support for the ‘Taiwan independence’ forces undermines peace across the Taiwan Strait and would only boomerang in the end,” Wang told Blinken, according to a readout of the call released by China on Saturday.

China has ramped up military activities near Taiwan in recent years, with a record number of planes intruding into the island’s air defense identification zone in early October.

Washington has repeatedly signaled its support for Taiwan in the face of what it has described as Chinese aggression.

‘Responsibly manage competition’

Biden has largely kept the tougher approach on Beijing of his predecessor Donald Trump, with both administrations seeing a rising China as the top challenge of the 21st century.

And while the world’s top two emitters of greenhouse gases unveiled a surprise agreement last week to work together on climate change, Washington and Beijing have indicated they will not give ground on flashpoint issues.

U.S. officials have framed Monday’s meeting as an opportunity to “responsibly manage competition” while trying to cooperate in areas where the two align.

Xi last week warned against the return of Cold War-era tensions in the Asia-Pacific region.

Biden and the Chinese leader have talked by phone twice since the veteran Democrat moved into the White House.

The pair also met extensively when Biden was Barack Obama’s vice president and Xi was vice president to Hu Jintao.

The U.S. president had hoped to meet Xi at a recent G-20 summit in Rome, but the Chinese leader has not traveled since the start of the COVID-19 pandemic and instead agreed to virtual talks by the end of the year.

Source: Voice of America

Philippine President’s Longtime Aide Turns To Run For President In 2022 Elections

MANILA– Philippine President, Rodrigo Duterte’s longtime aide-turned-senator, Christopher Go, yesterday turned to run for president in the 2022 elections.

Go, 47, filed last month, his certificate of candidacy for vice president at the Commission on Elections office, under the ruling PDP-Laban party.

But yesterday, he went back to the poll body in Manila with Duterte, to change his application, submitting his certificate of candidacy for president, as the standard-bearer of Pederalismo ng Dugong Dakilang Samahan (PDDS) party.

Go declined to comment on local reports that Duterte plans to run for vice president, saying, it is better to wait for the Philippine president’s decision in the coming days.

Earlier this week, Go hinted about changes in his plans in the 2022 elections, telling reporters that it was Duterte’s wish to change plans.

Yesterday, several minutes before Go’s filing, Duterte’s ally, Senator Ronald Dela Rosa, also went to the poll body, to withdraw his certificate of candidacy for president under PDP-Laban.

The poll body allows the substitution of candidates for the May, 2022 elections until Nov 15 (tomorrow). Under the rules, substitution is accepted, if a candidate dies, withdraws, or is disqualified by the poll body.

Duterte was elected president in the May, 2016 elections. The constitution limits Philippine presidents to a single six-year term.

Vice president is elected separately from the president, under the Philippine law.

Source: NAM NEWS NETWORK

Japan’s Former Princess Leaves for US With Commoner Husband

A Japanese princess who gave up her royal status to marry her commoner college sweetheart arrived in New York on Sunday, as the couple pursued happiness as newlyweds and left behind a nation that has criticized their romance.

The departure of Mako Komuro, the former Princess Mako, and Kei Komuro, both 30, was carried live by major Japanese broadcasters, showing them boarding a plane amid a flurry of camera flashes at Haneda Airport in Tokyo.

Photos posted online showed the couple arriving at JFK Airport.

Kei Komuro, a graduate of Fordham University law school, has a job at a New York law firm. He has yet to pass his bar exam, another piece of news that local media have used to attack him, although it is common to pass after multiple attempts.

“I love Mako,” he told reporters last month after registering their marriage in Tokyo. They did so without a wedding banquet or any of the other usual celebratory rituals.

“I want to live the only life I have with the person I love,” he said.

Although Japan appears modern in many ways, values about family relations and the status of women often are seen as somewhat antiquated, rooted in feudal practices.

Such views were accentuated in the public’s reaction to the marriage. Some Japanese feel they have a say in such matters because taxpayer money supports the imperial family system.

Other princesses have married commoners and left the palace. But Mako is the first to have drawn such a public outcry, including a frenzied reaction on social media and in local tabloids.

Speculation ranged from whether the couple could afford to live in Manhattan to how much money Kei Komuro would earn and if the former princess would end up financially supporting her husband.

Mako is the niece of Emperor Naruhito, who also married a commoner, Masako. Masako often suffered mentally in the cloistered, regulated life of the imperial family.

The negative media coverage surrounding Mako’s marriage gave her what palace doctors described last month as a form of traumatic stress disorder.

Former Emperor Akihito, the father of the current emperor, was the first member of the imperial family to marry a commoner. His father was the emperor under whom Japan fought in World War II.

The family holds no political power but serves as a symbol of the nation, attending ceremonial events and visiting disaster zones, and remains relatively popular.

Mako’s loss of royal status comes from the Imperial House Law, which allows only male succession. Only male royals have household names, while female imperial family members have only titles and must leave if they marry commoners.

Mako is the daughter of the emperor’s younger brother, and her 15-year-old brother is expected to eventually be emperor.

Complicating the former princess’s marriage, announced in 2017, was a financial dispute involving Kei Komuro’s mother. That issue was recently settled, according to Kyodo news service.

When Kei Komuro returned from the U.S. in September, the couple was reunited for the first time in three years. They met while attending Tokyo’s International Christian University a decade ago.

In announcing their marriage, the former princess, a museum curator, made her choice clear.

“He is someone I cannot do without,” she said. “Marriage is that decision needed for us to live on, staying true to our hearts.”

Source: Voice of America

Iran’s FM Urges “Serious” Approach For “Good Deal” In Upcoming Nuke Talks

TEHRAN – Iran’s Foreign Minister, Hossein Amir Abdollahian, called for a “serious” approach of the negotiating sides, in the upcoming nuclear talks, for a “good deal.” “I believe that, if the opposite sides enter the Vienna talks with a serious and positive approach, it will be possible to achieve a good agreement in a short time,” Amir Abdollahian was quoted as saying.

The Islamic Republic and the remaining parties to the 2015 nuclear deal, officially known as the Joint Comprehensive Plan of Action (JCPOA), are set to meet in the Austrian capital, Vienna on Nov 29, to resume negotiations, which were paused in June, due to Iran’s presidential election and the subsequent alteration in the administration.

“The Islamic Republic has no intention to be locked in the stalemate, remaining from the previous negotiations,” he said, urging for “effective and verifiable removal of (U.S.) sanctions and the return of the opposite sides to their full obligations” as the necessary steps for the progress of the talks.

Washington’s behaviour in imposing new sanctions against Iran has made providing “objective guarantees” an unavoidable necessity, he said, referring to Iranian officials’ persistence for the guarantees that the next U.S. administrations will not repeat the legacy of former U.S. President, Donald Trump by withdrawing from the deal and re-imposing sanctions.

Amir Abdollahian also pointed to the recent European tour of Iran’s nuclear negotiator, Ali Baqheri Kani, saying that, he has had “explicit and useful” talks in a number of European capitals, ahead of the scheduled reconvene of the talks.

The JCPOA Joint Commission is scheduled to reconvene in Vienna, with the participation of delegates from China, France, Germany, Russia, Britain, and Iran.

The United States, which terminated its participation in the agreement in May, 2018, is expected to engage in the talks indirectly.

Source: NAM NEWS NETWORK

Residents To Be Evacuated After Oil Refinery Tank Caught Fire In Central Java

JAKARTA – An oil refinery tank, in Indonesia’s Central Java province, caught fire last night, and residents living around the facility would be evacuated, as firefighters were battling the blaze, the country’s state oil and gas firm PT Pertamina said.

The company ensured in a statement that, the supplies of oil and liquefied petroleum gas for buyers were not disrupted by the accident.

The fire broke out at an oil refinery tank in Cilacap district, at about 7:20 p.m. Jakarta time, (1220 GMT), the statement said.

Earlier the company’s spokesman, Ifki Sukarya, said, the fire started at about 7:30 p.m. Jakarta time (1230 GMT).

“The efforts to extinguish the fire are intensively being carried out, using high capacity foam, monitors at the burned tank, and for the tanks located around it, water sprinkles are being used to cool them, in a bid to prevent further spread of the fire,” the statement said.

“Residents living around the fire site will be evacuated to safer grounds,” it said.

The Cilacap refinery is one of PT Pertamina’s six refineries. The refinery comprises 200 tanks for crude to be processed, as well as, oil and gas from crude oil processing.

Source: NAM NEWS NETWORK

Why Western Countries Back Taiwan Despite Their Pro-China Policies

Taiwan resident Freddy Lim has noticed his homeland has gotten an unusual amount of high-profile attention from other countries. Over the past four months, officials from two European countries, the European Parliament and the United States have made overtures to Taiwan. Lim, a member of the Taiwan parliament’s foreign relations committee, suspects a record was set.

“The reason is that international communication with Taiwan can start being put on the table now,” Lim said. “Before, of course, all countries were having communication with Taiwan, but in the past, it was all under the table.”

Lim is referring to most of the democratic world’s relationship with Taiwan over the years, with a history that goes back decades. China sees self-ruled, democratic Taiwan as part of its territory and has threatened force, if necessary, to bring the island under its flag — a leftover from the Chinese civil war of the 1940s when the Nationalists rebased in Taiwan after losing to the Communists on the mainland. Taiwan has formal diplomatic recognition from just 15 small countries worldwide, although informal relations with other countries do continue.

Western countries’ recent dealings with Taiwan serve as a warning to China, Taiwan’s longtime political rival, analysts said.

“By pulling together, they have more diplomatic clout and capability to negotiate with China together as opposed (to) on a one-to-one basis, and it’s a tactic that’s been used throughout history,” said Sean Su, an independent political analyst in Taiwan.

Other countries are teaming up in case China pushes too hard against Taiwan, dissenters in Hong Kong, or its own Muslim minority in the Xinjiang region — causes where democratic Western leaders often favor the pushed over the pusher, analysts said.

Surge of diplomatic support

Lithuania agreed in July to allow Taiwan to set up a representative office, leading China to recall its ambassador in Vilnius and warn of “potential consequences.” The Czech Republic’s senate president took a delegation of 89 leaders to Taiwan in August.

Last month, the European Parliament decided to deepen economic and diplomatic relations with Taiwan. A report that addressed the importance of economic ties between the European Union and Taiwan also raised concerns over China’s use of its military to pressure Taiwan.

State media China Daily reported that China’s Foreign Ministry spokesman, Wang Wenbin, said the European Parliament’s report “violates basic norms governing international relations and the one-China principle, (and) goes against the commitment made by the EU on the Taiwan question.”

Taiwan’s foreign minister visited Brussels at the end of October.

This week, four U.S. senators traveled to Taiwan.

Western leaders have tired of China’s “authoritarian” tendencies, said Derek Grossman, senior defense analyst with the U.S.-based Rand Corporation research organization.

“I think what we’re seeing with the Lithuanias of the world is sort of a banding together for a common cause, which is, we need to reject the authoritarian model in international affairs,” Grossman said. “If it comes to our shores, then it impacts us, or it has the potential to impact us, and that is manifested of course in support for Taiwan.”

Eastern European countries such as Lithuania and the Czech Republic have stepped out of the former Soviet Union-leaning East bloc of communist states.

Lithuania’s government now wants to “reduce dependence on autocratic regimes and to strengthen our political and economic relations with like-minded partners in the Indo-Pacific region,” the Baltic state’s Foreign Ministry said in a statement to VOA.

A critical mass of countries acting in Taiwan’s favor could help head off any conflict, said Stephen Nagy, senior associate professor of politics and international studies at International Christian University in Tokyo. China’s almost daily dispatch of military planes into Taiwan’s air defense identification zone since mid-2020 has raised fears offshore of a pending firefight.

Washington, for example, backs Taiwan through arms sales, naval ship passages near its coasts and senior-level visits.

On the peacemaking side, countries voicing support for Taiwan have said they plan to uphold their own “One China” polices, which means recognizing Beijing diplomatically over Taipei.

The Lithuanian Foreign Ministry said it “continues to adhere to a ‘One China’ policy” while developing relations with the “democratic and like-minded” Taiwan.

“I think we’re already seeing the movements towards trying to prevent a conflict between Taiwan and China, and that’s sending the strong signals through backdoor diplomacy that the ‘One China’ policy hasn’t shifted and they support peace and stability across the Taiwan Strait and that they don’t support either Taiwan independence or a forced reunification,” Nagy said.

Threat of Chinese retaliation

In the past, China has struck back at foreign opponents of its territorial interests by stopping military exchanges, halting talks and withdrawing support from its economy, the world’s second largest. China seldom opposes informal Taiwan-foreign trade and consular relations, including through de facto government offices, but it usually bristles when political or military exchanges take off.

A spokesperson for Beijing’s Taiwan Affairs Office said Monday the Taipei government’s “cooperation with external forces and continued ‘independence’ provocations” were the “root cause” for tension between the two sides, including the sending of a combined 700 Chinese aircraft into the Taiwanese air defense identification zone.

Taiwan President Tsai Ing-wen has said during her five years in office so far that countries that share her “democratic values” should support her.

Foreign countries have priced in China’s normal anger as they engage Taiwan, some analysts say. Retaliatory impacts depend on the size and influence of the country, Nagy said. Although China protested to Lithuania, he said, the small nation’s economic ties with China are minimal, giving it “more leeway” to act without fear of reprisal.

Countries such as India and Vietnam are eager to back one another economically “to make up the difference” in case of economic reprisals from China, Grossman said. Vietnam and India have spoken out against China over Asian sovereignty disputes.

Source: Voice of America