Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Users must ensure systems remain connected to power, conduct proper startup procedures, perform preoperative checks, and have emergency ventilation plans in place. Acknowledgment of receipt of the safety notice is required within 30 days.

Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.

Users must perform a software update to disable remote control and speed regulation for e-motion systems before January 1, 2021, using the Mobility application (version V01.004). For newer models, users need to safely store QR code labels after pairing.

Healthcare facilities are advised to adhere to standard acquisition protocols or modify parameters as recommended, with a requirement to respond to Philips within 30 days of notification.

Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.

All customers handling Infinion CX Leads must stop using these devices, segregate them, and return them to Boston Scientific as per the recall protocol communicated on June 17, 2026.

Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.

Users must carefully inspect the VentStar Resus Neo hoses for damages as per the product's Instructions for Use (IFU) and discard any hoses showing signs of cracks or detachments before use.