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In these situations, and in the judgment of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. Alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable.Do not stop or change ventilator use until you have talked to your health care provider.Ventilators: Recommendations for People Who Use Affected Ventilators At Home and Caregivers

Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.Register your device(s) on Philips Respironics’ recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA is requiring.Ozone cleaners may worsen the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories.Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.

Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

Using another similar device that is not part of the recall.

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:.

A-Series BiPAP Hybrid A30 (not marketed in US)Ĭontinuous Ventilator, Non-life SupportingīiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers.

Model Name and Number (All Serial Numbers)Ĭontinuous Ventilator, Minimum Ventilatory Support, Facility Use For details, see Philips’ Respironics recall notification (PDF). Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. SeptemUpdate : The FDA has taken additional actions related to the Philips Respironics ventilators, BiPAP, and CPAP recall.