Found 37 result(s) for "ANSM (France)".
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Affected healthcare facilities must archive the safety notification and submit responses to Philips regarding necessary safety measures within 30 days.
Healthcare facilities using the Haux-Starmed 2500/5,5/SC3 must initiate system modernization immediately and ensure that staff are trained in manual operation procedures, with a signed acknowledgment letter to be returned to Haux Life Support as soon as possible.
Users must acknowledge receipt of the safety notice, and distributors are required to inform all affected users promptly and ensure that the notice reaches all relevant parties.
Laboratories must quarantine and verify impacted lots immediately, and respond to the safety notice within 5 working days.
Users must send affected devices for repair to ensure continued safe operation. Notification of the issue must be disseminated to all users and organizations that have been supplied with the devices.
Users must identify the affected devices and take immediate action to cut the power supply by turning off circuit breakers. These actions should remain in effect for a period of 3 years.
Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.
Healthcare professionals should review the contraceptive needs of women annually and discuss the implications of continued desogestrel use, particularly in women over 45 or with a history of progestin use.
Integrate new protocols for screening and dosage adjustments for fluoropyrimidines in all healthcare establishments, alongside increased monitoring of DPD screening outcomes within pharmacovigilance processes.
Healthcare providers must implement mandatory DPD screening for all patients before starting fluoropyrimidine treatment and enhance monitoring for adverse effects.
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.
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.
Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.
Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.
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