(Reuters) — Dutch medical device maker Philips said on Tuesday that independent tests have shown that the use of its breathing devices involved in a major global recall did not pose health risks to patients.
Philips said “rigorous testing” by external parties on the range of DreamStation machines used to treat sleep apnea showed positive results, confirming preliminary results released last year.
“We are very pleased with these results, it is very important for patients to know that the use of the devices did not lead to any health risk,” Philips CEO Roy Jakobs told Reuters in a telephone interview.
“It proves that we have worked with a safe product, even if it can deteriorate.”
;Amsterdam-based Philips has been grappling with the fallout from the June 2021 global recall of millions of respirators used to treat sleep apnea over concerns that foam used in the machines could become toxic.
It said exposure to particulate emissions and volatile organic compounds from degraded foam in DreamStation units “would be unlikely to result in appreciable harm to the health of patients.”
Philips had already said last year that tests showed that foam breakdown was very rare and was linked to the use of unauthorized ozone-based cleaning products.
It now added that foam breakdown resulting from such cleaning would also not lead to significant damage.
Philips shares rose 3% in early trading in Amsterdam.
Philips has lost about 70% of its market value since it announced the recall, as investors feared huge legal bills from a series of lawsuits brought by worried patients.
The DreamStation machines included in the tests cover 95% of all recalled units, Philips said.
The company expects test results for the remaining 5% to be available in the third quarter of this year.
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