Philips provides update on Respironics recall
- Oct 6, 2023
- 2 minute read
Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall. We understand how important these sleep and respiratory care devices are to patients that use them.
Philips shares the same objective as the US Food and Drug Administration (FDA) and other regulators to ensure the highest standards of patient safety and quality in the delivery of healthcare. Philips remains committed to working closely with regulators across the world, as we continue to dedicate all necessary resources to ensure that patients receive remediated devices, and the test and research program is completed.
In the past two years Philips Respironics has been working cooperatively with the FDA on the test and research program and published regular test updates as agreed with the FDA.
Together with five independent, certified testing laboratories, Philips Respironics conducted extensive testing. Based on the results to date, Philips Respironics concluded that use of its sleep therapy devices are not expected to result in appreciable harm to health in patients.
Following ongoing communications with the FDA, Philips Respironics has agreed with the FDA’s recommendations to implement additional testing on certain sleep and respiratory care devices to supplement current test data.
The FDA stated that the testing is extensive and conducted with independent parties and expressed no concerns with the validity or objectivity of the testing. Philips Respironics is still in discussions with the FDA on the details of further testing.
Philips is committed to securing patient safety and quality in everything we do.
