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Health Canada Medical devices

Essenz HLM

Issued January 22, 2025
Issue
LivaNova has received reports of the Cockpit Graphical User Interface (GUI) of the Essenz HLM with SW HLM.1.5 activating a self-resetting safety feature, with the operation of the GUI being restored during use. During the reported events, the touchscreen display has temporarily gone dark (black/grey) and reset back to the home screen after approximately 10-15 seconds. Recall Start Date: October 18, 2024
Hazard description
Performance
Product
Product name
Essenz HLM
Reference
ID
RA-76842