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ESSENZ recallZ-0571-2025 · LivaNova Deutschland GmbH · initiated Oct 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LivaNova Deutschland GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software change control

What the company is doing

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].

Recall details

Recall number
Z-0571-2025
Status
Open, Classified
Initiated by the company
Oct 18, 2024
Posted by the FDA
Nov 27, 2024
Recalling firm
LivaNova Deutschland GmbH
Quantity
38
Product code
DTQ
FDA submissions
K232291
Distribution
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

10 devices cleared under K232291 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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