Overview

• Cofepris directed hospitals and distribution warehouses to immobilize and segregate Philips E30 units and related devices and requested the supplier to take them back.
• Medical units must report actions to the National Center for Pharmacovigilance and Tecnovigilance with counts, models and distributor details.
• The order covers more than fifteen models, including E30, Trilogy 100 and 200, DreamStation and several A‑Series BiPAP variants.
• Forty‑three patients and relatives filed a collective civil suit and a criminal complaint this week alleging injuries and deaths tied to more than 3,500 devices still in use.
• The devices entered Mexico under emergency authorizations in 2020 after which the FDA warned in 2021 about defects, yet large‑scale removals in Mexico stalled amid legal disputes that include conflicts with an authorized distributor and a reported €50 million claim against the government.