131
edits
Changes
→Timeline
::''Mick Farrell''
::''CEO, ResMed''
===July 21, 2021 - FDA has identified this as a Class I recall===
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.<br />
There are 2 entries on the FDA site, one for Risk of Exposure to Debris and Chemicals and the other Due to Potential Health Risks from PE-PUR Sound Abatement Foam <br />
[https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-continuous-and-non-continuous-ventilators-including-cpap-and Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals] <br />
[https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-ventilators-and-bipap-machines-due-potential-health-risks-pe-pur Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam]
==Health Issues==
Donate to Apnea Board
