Neonatal incubator safety alert: Lifetherm 2000

ANSM Drug & Device Safety Alerts

Published March 16th, 2026

Detected March 16th, 2026

Summary

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert (R2607231) concerning the Lifetherm 2000 neonatal incubator, manufactured by Löwenstein Medical GmbH & Co. KG. This alert specifically targets a single healthcare facility and is accompanied by a letter from the manufacturer detailing the safety action being implemented. The document indicates a recall or corrective action is underway for this medical device.

Healthcare providers using the Lifetherm 2000 incubator should review the manufacturer's letter and follow any instructions provided to ensure patient safety. Compliance officers should verify if their facility is the one identified and ensure all recommended actions are taken promptly. Further details on the specific safety issue and required actions are contained within the linked manufacturer's letter.

What to do next

Review manufacturer's safety action letter for Lifetherm 2000 incubators
Implement any recommended corrective actions or procedures

Source document (simplified)

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Information n° R2607231 destinée aux pharmacies d'usage intérieur Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607231. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.

L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Löwenstein Medical GmbH & Co. KG.

L’unique établissement de santé concerné a reçu le courrier ci-joint. Téléchargez le courrier de la société Löwenstein Medical GmbH & Co. KG. (16/03/2026)