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Essenz HLM — recall 76842

Health Canada — Medical Devices · Canada · 2025-01-22 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 76842
Date of alert: 2025-01-22
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Cardiovascular
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/essenz-hlm

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Essenz HLM — recall 76842

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