FDA-Device2023-10-18Class II
3T Heater Cooler System, REF: 16-02-85
LivaNova Deutschland GmbH
Hazard
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Sold states
US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
Affected count
37 systems
Manufactured in
Lindberghstr. 25, N/A, Munich, N/A, Germany
Products
3T Heater Cooler System, REF: 16-02-85
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief