Z-0571-2025Class II

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

Name: Z-0571-2025 Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Creator: LivaNova Deutschland GmbH
Published: 2024-10-18
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2024-10-18 / Open, Classified / root cause: software

FDA source

LivaNova Deutschland GmbH began a recall of Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software on 2024-10-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0571-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-18
Posted: 2024-11-27
Recalling firm: LivaNova Deutschland GmbH
Product: Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: software
FDA root cause: Software change control
Action: On 10/18/24, a correction notice was emailed to customers: 1. Continue using the Heart-Lung Machine with SW HLM.1.5 as intended. 2. In the event of any cockpit reset during a procedure, use the backup control panel to make any setting adjustments as described in HLM IFU section 3.3.2 "Backup control panel." A. When prompted, press the "LAST CASE" button to retrieve the previous settings as described in HLM IFU chapter "7.1.3 Returning to the last case." If the gas blender settings were manually changed prior to the reset, adjust the settings as needed. B. If after selecting the "LAST CASE" button a second reset occurs, the "LAST CASE" button may not be available. Throughout the resetting of the system, the HLM's essential functions, including the pumps, alarms, sensors, and safety features, continue to operate as intended. After the second reset, the Gas Blender may go to Standby. If this occurs, the operator should reactivate the Gas Blender from the user interface on the Gas Blender unit to maintain operation of the Gas Blender for the procedure. After the second reset, a new case should be started from the home screen; while the machine distributes the profile again, the sensors are momentarily deactivated until the user selects the start case button. The user can skip the safety checks since they have already been performed before the reset and enter bypass mode. After starting the case, the user should update the case settings as needed. The start Case function is described in HLM IFU chapter "7.1.1 Starting a case" 3. Complete/return the response form to [email protected] 4. Communicate the Correction to all personnel within your organization and any organization where affected devices have been transferred. Firm to contact customers to schedule a software update, available no later than 10/31/24. For questions regarding the correction, contact the firm at: [email protected].
Quantity in commerce: 38
Distribution: US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-27

Product code DTQ

K232291Class IIEssenz HLM, Essenz ILBMLivanova Deutschland, GmbH / cleared 2023-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)