Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.įDA Recommendations for Caregivers and At-Home Users of Affected VentilatorsįDA cautions ventilator users not to stop or change ventilator use until speaking with a health care provider.Register your device(s) on Philips Respironics’ recall website External Link Disclaimer 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.Continuing to use your affected device, if your health care provider determines the benefits outweigh risks identified in the recall notification.įDA further recommends that those concerned:.Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, ceasing smoking, or even considering surgical options.Using alternative treatments for sleep apnea, such as positional therapy or oral appliances that fit like a sports mouth guard or an orthodontic retainer.
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FDA recommends talking to your health care provider to decide on a suitable treatment for your condition.Recommendations for Caregivers and Users affected by BiPAP or CPAP Machines A-Series BiPAP Hybrid A30 (not marketed in US).
PHILIPS RECALLS CPAP MACHINES SERIAL
Model Name and Number (All Serial Numbers)Ĭontinuous Ventilator, Minimum Ventilatory Support, Facility UseĬontinuous Ventilator, Non-life Supporting For details, see Philips’ Respironics recall notification External Link Disclaimer (PDF). Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. The agency said that those who use one of the affected devices should speak with a health care provider to decide on a suitable treatment for their condition and follow the recommendationsthe agency lists. 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.”
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The FDA said in a safety communication that polyester-based polyurethane (PE-PUR) sound abatement foam in these affected devices “may break down and potentially enter the device’s air pathway. Food and Drug Administration (FDA) announced it was alerting health care providers and people who use Philips Respironics ventilators, BiPAP, and CPAP machines that Philips Respironics has recalled certain devices (see below) due to potential health risks. Philips Respironics Ventilators, BiPAP, CPAP Machines recalled due to potential health risks On June 30, 2021, The U.S.
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