Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3T Heater Cooler System Recalled by LivaNova Deutschland GmbH Due to The firm's labeling (Quick Reference Guide) contains incorrect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova Deutschland GmbH directly.
Affected Products
3T Heater Cooler System, REF: 16-02-85
Quantity: 37 systems
Why Was This Recalled?
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LivaNova Deutschland GmbH
LivaNova Deutschland GmbH has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report