Overview
- Hospitals and distribution warehouses must segregate Philips ventilators from use and request immediate pickup by suppliers under the new directive.
- The order covers multiple models, including E30, DreamStation lines, Trilogy 100 and 200, and A-Series BiPAP, as specified in the official notice.
- Facilities must report actions taken and detailed inventories to the Centro Nacional de Farmacovigilancia y Tecnovigilancia, including model counts and distributor names.
- Philips devices entered Mexico in 2020 under emergency authorization, while the FDA flagged serious defects in 2021 involving degraded foam, calibration problems, particle release and unexpected shutdowns.
- Forty-three patients and relatives filed a collective suit alleging injuries and deaths linked to the devices and accusing Philips México of failing to remove them, as legal disputes continue over responsibility and reported claims for €50 million.