Recall Z-0571-2025 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
LivaNova Deutschland GmbH
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
| Date | Nov 27, 2024 (initiated Oct 18, 2024) |
| Status | Open, Classified |
| 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" bu |
| Quantity | 38 |
| Distribution | US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232291 | Essenz HLM, Essenz ILBM Livanova Deutschland, GmbH, Aug 24, 2023 |