LivaNova Deutschland recalls
3 official recalls and safety alerts involving LivaNova Deutschland since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with LivaNova Deutschland or the relevant agency.
- 2024-12-04
USLivaNova Deutschland GmbH recalls Essenz 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…
FDA · DeviceLivaNova Deutschland GmbHUS Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.Official notice →- 2023-10-18
- US
LivaNova Deutschland GmbH recalls 3T 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.
FDA · DeviceLivaNova Deutschland GmbHUS Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN,…Official notice → - 2022-03-23
- US
LivaNova Deutschland GmbH recalls Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System…
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.