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

Recall number

Z-0571-2025

Recalling firm

LivaNova Deutschland GmbH

Product

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

Status

Open, Classified

Initiated

2024-10-18

Posted

2024-11-27

Terminated

not on file

Reason

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

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 LivaNova.FSCA@livanova.com 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: LivaNova.FSCA@livanova.com.

Quantity

38

Distribution

US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

Lot, serial or model codes

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

510(k) numbers

["K232291"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

3002808267

Firm city

Munich

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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