Class II — LivaNova Deutschland GmbH
| Recalling firm | LivaNova Deutschland GmbH |
|---|---|
| Registered facility | LivaNova Deutschland GmbH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. |
| Product | 3T Heater Cooler System, REF: 16-02-85 |
| Quantity | 37 systems |
| Distribution | US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC. |
| Initiated | 2023-08-03 |
| Classified | 2023-10-06 |
| Recall number | Z-0073-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LivaNova Deutschland GmbH (Z-0073-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92882/
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