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Philips Reaches Settlement Over CPAP Recall

Philips has reached an agreement to resolve all economic loss claims related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices.

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Philips CEO: Resolving Recall Remains ‘Our Highest Priority’

Philips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.

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Philips Provides Update on Test Results for 1st-Gen DreamStations

More test results and assessments are now complete for recalled first-generation Philips Respironics DreamStation devices, including new data on particulate matter and VOC emissions.

FDA: Philips Respironics Recall Classified as Level I

Oct 19, 2022 | CPAP & PAP Devices

The new classification comes after the FDA announced a Philips Respironics recall of certain BiPAP and CPAP masks due to a serious safety concern related to magnetic headgear clips that may cause harm to people who have implanted medical devices.

Philips Warns of Lower-Than-Forecast Sales for Q3 2022 Due to Supply Chain Challenges

Oct 14, 2022 | CPAP & PAP Devices

Philips’ performance in the third quarter was impacted by continued supply chain challenges that were more significant than anticipated.

Philips Publishes New Test Results for Recalled CPAP Devices

Jun 28, 2022 | CPAP & PAP Devices, Obstructive Sleep Apnea

Testing was performed on new devices (pristine foam), devices with lab-aged foam, and used devices. Philips shares test results to date.

Green Pharmaceuticals Recalls SnoreStop NasoSpray Lot

Jun 15, 2022 | FDA, Snoring

Camarillo, Calif-based Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray.

Philips Provides Update on Medical Device Reports Linked to Recall

May 24, 2022 | CPAP & PAP Devices, Obstructive Sleep Apnea

Philips’ public statements in April 2021, as well as the recall announcement in June, led to an increase in filed medical device reports.

FDA Proposes Philips Offer Refunds as Option in CPAP Recall

May 3, 2022 | CPAP & PAP Devices, FDA

Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price.

Philips Ups Staffing Related to CPAP Recall

Apr 27, 2022 | CPAP & PAP Devices, Obstructive Sleep Apnea

Management responsibility and oversight have been strengthened with organizational changes implemented in Philips Respironics.

FDA Recommends Philips Prioritize CPAP Recall Replacements for Most Vulnerable

Mar 23, 2022 | CPAP & PAP Devices, FDA, Obstructive Sleep Apnea

A first-come, first-served replacement strategy may not address patient health risks, so the FDA has recommended a prioritization approach.

Philips Recall: 650,000+ Replacements Shipped So Far

Mar 15, 2022 | CPAP & PAP Devices, Obstructive Sleep Apnea

Philips Respironics aims to complete the repair and replacement program for its CPAP recall in the fourth quarter of 2022.

FDA Orders Philips Respironics to Notify Patients of Recall for CPAP Devices, Ventilators

Mar 11, 2022 | CPAP & PAP Devices, FDA

“The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate,” the agency wrote in a news alert.

ResMed Works to ‘Meet the Extraordinary Demand Generated By Our Competitor’s Ongoing Device Recall’

Jan 31, 2022 | CPAP & PAP Devices

‘We are working every day to meet the extraordinary demand generated by our competitor’s ongoing device recall.’

CPAP Recall: Philips Releases Update on Health Risk

Dec 23, 2021 | CPAP & PAP Devices

A research assessment looked at the levels of VOCs identified in first-generation DreamStation devices.

FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices

Nov 17, 2021 | CPAP & PAP Devices, FDA, Obstructive Sleep Apnea

During the manufacturing facility inspection, the FDA obtained additional information regarding the silicone-based foam used in a device outside the United States that failed one safety test for the release of VOCs.