LivaNova Deutschland GmbH: Device Recall
Recall #Z-0571-2025 · 10/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0571-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- LivaNova Deutschland GmbH
- Status
- Ongoing
- Date Initiated
- 10/18/2024
- Location
- Munich, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
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.
Product Description
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Distribution Pattern
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.