NADAL® Rota-Adenovirus Test Urgent Safety Notice - Nal Von Minden
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.
Primary source: Téléchargez le courrier de la société Haux Life Support (10/09/2026)
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The ANSM advised the immediate modernization of the obsolete automatic control system of the Haux-Starmed 2500/5,5/SC3 hyperbaric chamber and emphasized the importance of manual operation procedures during system failures.
Failure to modernize the control system may lead to technical problems that could affect patient safety, thus highlighting the urgency for healthcare facilities to act promptly.
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.
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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.
The ANSM (French National Agency for the Safety of Medicines and Health Products) has issued a safety information notice regarding the Haux-Starmed 2500/5,5/SC3 hyperbaric chamber. The notice highlights that the automatic control system is obsolete, posing potential risks. Immediate modernization of this system is recommended to mitigate technical problems. Operators are urged to familiarize themselves with emergency manual operation procedures.
What changed: The ANSM advised the immediate modernization of the obsolete automatic control system of the Haux-Starmed 2500/5,5/SC3 hyperbaric chamber and emphasized the importance of manual operation procedures during system failures.
Why it matters: Failure to modernize the control system may lead to technical problems that could affect patient safety, thus highlighting the urgency for healthcare facilities to act promptly.
Practical implication: 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.
Published from the regulator source ingestion pipeline after PV impact triage.
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.