The FDA published a warning letter that it sent to Philips (NYSE:PHG) that outlines issues around imaging technology ...
Philips Respironics will continue to prioritize completing the remediation of the sleep and respiratory care devices under Respironics’ voluntary June 2021 recall.
The recall ultimately grew to include about 5. ... the increased scrutiny will help us to improve even more,” said Philips CEO Roy Jakobs. “With the agreement on a consent decree for Philips ...
CEO Roy Jakobs in January noted on ... Under the terms of the agreement, Philips Respironics will continue the recall. The company said that more than 99% of the sleep therapy devices have been ...
At the time of the recall, both Philips and the FDA described potential health risks including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects. The FDA has said ...
In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” ...
The decree also requires implementation of a Recall Remediation Plan, agreed to by the FDA and Philips Respironics, to help ensure relief is provided to patients impacted by Philips Respironics ...