Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Summary
The FDA issued a Class II for Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software by LivaNova Deutschland GmbH. Reason: Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained thr.
Details
Source
Device Recall
External ID
Z-0571-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Lot/Code Info: UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288
Quantity Affected: 38
Reason for Recall
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
Distribution
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-18
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LivaNova Deutschland GmbH has 7 FDA actions in our database, including 3 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LivaNova Deutschland GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LivaNova Deutschland GmbH have FDA actions?
LivaNova Deutschland GmbH has 7 FDA actions in our database, including 3 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0571-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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