Use caution Medical device recall · FDA · Published October 18, 2024

LivaNova Essenz HLM Heart-Lung Machine Software Issue: Short GUI Blackouts Risk Hypoxia

LivaNova recalls Essenz HLM heart-lung machines with software version 1.5 due to touchscreen blackouts that may cause hypoxia. Affected units have specific serial numbers and were sold in Germany.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0571-2025Medical device LivaNova ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmLivaNova Deutschland GmbHLindberghstr. 25 · Munich, Germany

✎ GovInfoNow plain-language explainer

LivaNova is recalling heart-lung machines with software version 1.5 because brief touchscreen blackouts could lead to hypoxia (low oxygen) and hypoperfusion (inadequate blood flow). This is a serious risk during medical procedures. Read more at govinfonow.com/recall/53682-livanova-essenz-hlm-heart-lung-machine-software-issue-short-gui.

Source Summary by GovInfoNow · govinfonow.com/recall/53682-livanova-essenz-hlm-heart-lung-machine-software-issue-short-gui · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0571-2025

Cite this page

“LivaNova Essenz HLM Heart-Lung Machine Software Issue: Short GUI Blackouts Risk Hypoxia.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53682-livanova-essenz-hlm-heart-lung-machine-software-issue-short-gui. Based on FDA recall #Z-0571-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0571-2025%22&limit=1).

The FDA announced on Oct. 18, 2024, that LivaNova Deutschland GmbH is recalling Essenz HLM Heart-Lung Machines due to a touchscreen hazard. The agency issued recall number Z-0571-2025 for the voluntary Class II action affecting 38 units distributed nationwide.

How to tell if you have it

Brand: LivaNova
Product: Essenz HLM (Heart-Lung Machine)
REF: 49-00-10
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

The hazard

According to the FDA, the Essenz HLM Heart-Lung Machine's GUI touchscreen may go dark for 10-15 seconds while safety functions remain operational. A second reset may cause the gas blender to enter standby mode and deactivate sensors until a new case is started. This reset can lead to hypoxia and hypoperfusion.

Context

GovInfoNow's records show LivaNova Deutschland GmbH has issued three other recalls since Aug. 26, 2019. On Dec. 17, 2021, the firm recalled CP5 Drive Units due to a missing ferrite ring risk. Other recent recalls of similar products include Medline Oxygen Masks Recall (Nov. 21, 2025) and Baxter Blue Ventilator Adapter Module Recall (Feb. 18, 2026).

How to tell if you have this one

Check for the serial numbers listed in the recall notice (e.g., 49PK00436, 49PK00108). The software version is 1.5, and these units were sold in Germany.

Brand
LivaNova
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version is 1.5 by checking the machine's display or documentation.
Monitor for Blackouts
Watch for brief touchscreen blackouts (10-15 seconds) that may require manual reactivation of gas blenders.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

FDA distribution: “US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Georgia, Indiana, Mississippi, Nevada, New Jersey, Virginia.

Recall timeline

FDA published this recall 47 days after the firm started it.

Oct 18, 2024Firm started the recall
Nov 27, 2024FDA classified it Class II
Dec 4, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53682-livanova-essenz-hlm-heart-lung-machine-software-issue-short-gui">LivaNova Essenz HLM Heart-Lung Machine Software Issue: Short GUI Blackouts Risk Hypoxia (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0571-2025 (October 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0571-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.