Posted 4/9/2024, 10:37:14 PM
Philips Ordered to Overhaul Manufacturing After Recall of 5M Potentially Hazardous Sleep Apnea Machines
- Philips ordered by court to overhaul manufacturing and improve quality control due to defective sleep apnea machines
- Must hire independent experts to vet changes and get FDA approval on new foam safety
- More than 5 million machines recalled since 2021 due to breaking down foam particles and fumes
- 750+ lawsuits filed against Philips over the defective devices
- FDA found Philips was warned of foam issues 6 years before recall but did not take corrective action
