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Philips – XtremeCuztoms

Category: Philips

Philips Clarifies Respiratory Device Replacement Numbers After New FDA Rebuke

AMSTERDAM—Philips clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States. The Dutch healthcare equipment maker issued a statement on April 14 clarifying progress of the recall program underway since 2021 after the Food and Drug Administration…


FDA Identifies Recall of Philips Respiratory Devices as Most Serious

The Food and Drug Administration (FDA) on Friday classified the recall of Philips’s respiratory machines as its most serious type, as their use could cause serious injuries or death. The Dutch medical devices maker’s unit Philips Respironics recalled 1,088 devices in the United States on Feb. 10. These devices help people with respiratory conditions to…


Philips Says Tests on Recalled Products Show Limited Health Risks

AMSTERDAM—Dutch health technology company Philips said on Wednesday independent tests on its respiratory devices involved in a major global recall had shown limited health risks. The company rocked investors last year by recalling millions of breathing devices and ventilators used to treat sleep apnea, because foam used to dampen noise from the devices might degrade…


Philips to Cut 5 Percent of Workforce as New CEO Acts to Counter Falling Sales

AMSTERDAM—Philips’ new CEO announced plans on Monday to cut around 4,000 jobs following falling sales and after a massive recall slashed around 70 percent off the Dutch medical equipment maker’s market value in the past year. “We have now had five quarters of declining sales, declining profit, and now … (in the third quarter) we…


Philips Recalls Some Masks Used With Respiratory Devices Over Safety Concerns

The U.S. Food and Drug Administration said on Tuesday that medical device maker Philips has recalled certain masks used with some of its respiratory machines due to potential risk of serious injury. The masks have magnetic headgear clips or straps which can interfere with certain implanted metallic medical devices and metallic objects in the body…


Philips Subsidiary to Pay Over $24 Million for Alleged False Claims for Medical Equipment

WASHINGTON—A subsidiary of Dutch medical device maker Philips has agreed to pay over $24 million to resolve alleged false claims over respiratory-related medical equipment, the U.S. Justice Department said on Thursday. The subsidiary, Philips RS North America LLC, formerly known as Respironics Inc., resolved allegations that it misled federal healthcare programs by paying kickbacks to…


Philips Expands Respiratory Devices Recall on Possible Plastic Contamination

Dutch medical device maker Philips said on Monday it has expanded an earlier recall of some respiratory machines to a total of 1,700 devices globally due to possible contamination of a plastic component with a non-compatible material. The company’s subsidiary, Philips Respironics, has not received any reports of patient harm due to the issue but…


Philips Parts Ways With CEO in Midst of Massive Recall

AMSTERDAM—Philips Chief Executive Frans van Houten will leave the company in October, the Dutch health technology firm said on Tuesday, after a key product recall cut its market value by more than half over the past year. Philips said Van Houten would be replaced on Oct. 15 by Roy Jakobs, head of the company’s Connected…


Philips Shares Slide as Shortages and Recall Hit Profits

AMSTERDAM—Philips shares plunged more than 11 percent on Wednesday morning after the Dutch health technology company hiked the cost of its massive recall of ventilators and said earnings would take a big hit from global supply chain shortages. The supplier of hospital equipment and personal health devices said it expected fourth-quarter core profit to drop…


Philips Ventilator Recall Troubles Deepen as FDA Finds New Issues

The U.S. Food and Drug Administration (FDA) has asked Philips to conduct more tests on the foam used in its recalled ventilators, after the agency found several new issues at the Dutch company’s manufacturing facility. The medical equipment company recalled some breathing devices and ventilators in June because of a silicone-based foam part that might…