Recall Z-0571-2025— LivaNova Deutschland GmbH
Class II · Ongoing
Class II FDA medical device recall by LivaNova Deutschland GmbH, initiated 2024-10-18. It names one FDA 510(k) clearance: K232291. Product: Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software. 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..
- Recalling firm
- LivaNova Deutschland GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-18
- Firm location
- Munich, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.