Recall Monitor
Health Products

Essenz HLM

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Essenz HLM
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Essenz HLM49PK00427
49PK00012
49PK00047
49PK00432
49PK00048
49PK00426
49PK00430
49PK00045
49PK00429
49PK00433
49PK00424
49PK00419		49-00-10

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

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