A court has ordered the Dutch medical device company Philips and its subsidiary, Respironics, to stop making sleep apnea machines in the US until they resolve a slew of manufacturing issues. The case was brought against Philips by the Department of Justice (DOJ) on behalf of the Food and Drug Administration (FDA) after the company failed to fix potentially fatal flaws in its devices.
The US District Court for the Western District of Pennsylvania issued a consent decree of permanent injunction on 9 April against Philips, Respironics, and several defendants, including Royal Philips CEO Roy Jakobs, to stop the company from manufacturing new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and ventilators at Philips Respironics facilities in Pennsylvania and California. It also means the company must immediately implement a Recall Remediation Plan that it has agreed to with FDA. (RELATED: FDA inspection turns up more problems for Philips Respironics, Regulatory Focus 16 November 2021)…
