LivaNova Deutschland GmbH has recalled 38 Essenz Heart-Lung Machines (HLM), model REF: 49-00-10 with Software Version 1.5, because the touchscreen display may go dark for 10 to 15 seconds. If this failure occurs, the gas blender may enter standby mode, requiring the user to manually reactivate it using the interface located directly on the blender. While safety and performance functions remain operational via a backup control panel, a second reset could occur, deactivating sensors until a new case is started. No injuries have been reported to date.
A display failure during a medical procedure could lead to hypoxia (lack of oxygen in the blood) or hypoperfusion (decreased blood flow), both of which are life-threatening conditions for patients undergoing cardiac surgery.
Recall #: Z-0571-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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