Translated From French

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Clinics and healthcare facilities are required to verify their inventory immediately and isolate any affected units to prevent accidental use.

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

Health professionals must ensure adherence to the manufacturer’s instructions when using the affected devices, including appropriate trocar size selection and avoiding excessive force.

Establish compliant storage conditions for medical devices and set up a non-conformity management system within 3 months.

Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.

Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.

Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

Healthcare professionals must act on the issued FSNs as outlined by MHRA, ensuring compliance to address any safety concerns associated with the listed medical devices.

Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.

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.

Healthcare facilities must initiate the removal process for affected lots, isolate impacted products, and communicate the recall information to all relevant healthcare professionals. Compliance with the outlined return process is mandatory.

Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.

Pharmacovigilance systems must be updated to monitor and report on the newly added medications.

Ensure compliance with the updated reference list and adjust internal regulatory monitoring processes to align with the inclusion of new biologicals.

Increased vigilance and reporting obligations on illegal peptide products, with an emphasis on monitoring and managing safety signals pertaining to these substances.

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.

All users of the affected analyzers are required to reply to the notification letter within 10 days and implement increased monitoring of device performance to prevent liquid leaks.

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

Health agencies should integrate and evaluate passive digital monitoring data, such as cough signals from sleep apps, alongside traditional surveillance systems to enhance early warning capabilities.