HQ Team
December 21, 2022: Koninklijke Philips N.V., Amsterdam-based healthcare technology company, said independent tests on its respiratory devices that were recalled in June 2021 showed negligent health risks.
Philips Respironics carried out a comprehensive test and research program for the CPAP, BiPAP and mechanical ventilator devices. There were concerns that the foam used to dampen noise from the devices might degrade and become toxic, carrying potential cancer risks.
“We can state that the whole product complies with safety norms. That is very encouraging news,” Chief Executive Roy Jakobs told Reuters.
Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients”, provided the machines had not been treated with ozone-based cleansing products.
The recall resulted in the company losing 70% of its market value. Net income in the third quarter ended September amounted to a loss of 1.3 billion euros, mainly due to a charge of 1.3 billion euros related to an “impairment of goodwill” in the Sleep & Respiratory Care business.
Following the FDA’s inspection of certain Philips Respironics facilities in the US in 2021, the US Department of Justice, acting on behalf of the FDA, began discussions with Philips in July 2022 regarding the terms of a proposed consent decree to resolve the identified issues.
Philips Respironics, subject to an investigation by the US Department of Justice, is a defendant in several class-action lawsuits and individual personal injury claims and is in ongoing discussions with the FDA regarding the proposed consent decree.
The U.S. Food and Drug Administration (FDA) is still considering the results and “may reach different conclusions,” Philips said. The test and research program has been conducted 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 company said in its press release.
