LivaNova Deutschland GmbH
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for LivaNova Deutschland GmbH and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-12-04FDA-DeviceClass IIEssenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
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.
- 2023-10-18FDA-DeviceClass II3T Heater Cooler System, REF: 16-02-85
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
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