Essenz HLM
Brand(s)
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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