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Essenz hlm

Official notice

22 Jan 2025

Last checked

22 Jan 2025

Medium riskHealth Canada

An official Health Canada notice concerns Essenz hlm. 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 Published 2025-01-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76842

Official notice

2025-01-22

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76842

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Affected products

Product 1

Affected products - Essenz HLM, Lot or serial number - 49PK00427 49PK00012 49PK00047 49PK00432 49PK00048 49PK00426 49PK00430 49PK00045 49PK00429 49PK00433 49PK00424 49PK00419, Model or catalog number - 49-00-10

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Livanova Deutschland, Essenz Hlm.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76842

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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