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# Class 1 Recall on Philips Respironics Ventilators
- URL: https://www.fdaweb.com/class-1-recall-on-philips-respironics-ventilators/
- Published: 2022-03-21T12:00:00.000Z
- Updated: 2026-09-14T17:37:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151416

FDA has classified as Class 1 a Philips Respironics recall of certain V60 and V60 Plus ventilators because some of the devices had parts that were put together using an expired adhesive. “If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient,” according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-v60-and-v60-plus-ventilators-expired-adhesive-may-cause?ref=fdaweb.com). “This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all.” To date, the company says no adverse event reports have been received related to the device issue.

Philips Respironics has struggled with ventilator recalls over the past few years. Most recently, on 3/11 FDA issued a rare [Section 518(a)](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3NbUdLzFfkAclTghtHjy3-2Bt7UGomlqrF-2BFUfe-2BO7kt7I-2FIQ0skxfLYWNV3TTrOX683mX7h-2FS99mS256-2BEQdNu2U9BXfQjOC-2FylbJPJ4m655Ufyx2TccpPbJwti-2FJwICMR4-3Dnr2F%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQfaeuE-2BCI-2BCfREgc2ey8ZTGplX59tX-2BosOHyd7oXqzfeyxOCs-2BatljpQSp9PlbHqH6Ftg2e0q6psOM-2B-2BTgEbsWmBaeKAXN-2BcIMvdDZuNDfZgRbX2AFtVfvD0q-2FtlNZv2JYUk-2F-2BN2n9T6OPNcTV2cBcvU-3D&ref=fdaweb.com) notification order “requiring the company to notify patients and others of the company’s 6/14/2021 recall of certain ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products.” The [notification order](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZAmdierth9sDznGHUIlSHO9ei4TFsJLd8vCd6yy0SwYqCDyl3PlnVprxjkojIZPkAA-3D-3DdWuB%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigCiXICIZPB4RGigCdTzpK2QgEtecQr07-2BqexlLIBD5kNw-2FavX-2BYh44pnfMa5xoVEfZ7c4fPTuxxLTO6Td0XyBUFDw0jqyBYL9AtNHmnJxERaTLj7pnnzkbgC4GWXLMPVWu3m2aR3zMnuyOCMPLjWQffY5y-2FvyYGLXpqh-2BxoS5dZtWYvrxDkplKo4th2-2Fg4gIKlOB6vR0Iq55SnE7gjZ6E57uEFMVZnXrbp57sLNXoQzjGpD-2FgMJyMTApdypmOMIPkrQpzxJHY4HtE39hp0aMirozlHNkkQpMXIp-2FJ-2BqbED2A-3D&ref=fdaweb.com) was necessary due to what the agency described as “inadequate” company notification efforts to date.

Last year, FDA inspected Philips and issued a [29-page Form FDA-483](https://www.fda.gov/media/154099/download?utm%5Fmedium=email&utm%5Fsource=govdelivery) based on a Class 1 recall follow-up involving the continuous and non-continuous ventilators, which are used to provide respiratory support or treatment for sleep disorders. The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration. An earlier [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-continuous-and-non-continuous-ventilators-including-cpap-and?ref=fdaweb.com) said the foam may break down and enter the device’s air pathway. “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 notice says, adding that exposure to debris or chemicals could cause serious adverse events in patients. There have been more than 1,200 complaints and more than 100 injuries reported on the issue.