Health product recall

Essenz HLM

Last updated

Summary

Product
Essenz HLM
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Essenz HLM

49PK00427
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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Livanova Deutschland Gmbh

Lindberghstrasse 25, Munich, Germany, 80939

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76842

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