LivaNova recalls 3T Heater Cooler Systems with incorrect maintenance labeling in Quick Reference Guides. Affected units may require correction to prevent improper maintenance.
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
LivaNova is recalling specific models of 3T Heater Cooler Systems due to incorrect maintenance instructions in their Quick Reference Guides. This could lead to improper maintenance if users follow outdated schedules.
The Quick Reference Guide contains incorrect maintenance schedules, which could result in improper maintenance if users follow outdated instructions. This might lead to equipment malfunction but does not pose an immediate safety risk.
Medical professionals using the 3T Heater Cooler System for patient care are most at risk. The recall affects specific serial numbers sold in the U.S. market.
Check for the model number 3T Heater Cooler System with serial numbers listed in the recall notice. The affected units have specific serial numbers starting with 20T31334 through 20T31553.
Identify the serial number on your 3T Heater Cooler System to see if it matches the listed numbers in the recall.
The Quick Reference Guide contains incorrect maintenance schedules that could lead to improper maintenance if users follow outdated instructions.
No, but you should check the serial number to see if your unit is affected. If it is, you may need to correct the maintenance schedule.
Check the serial number against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0073-2024 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0073-2024 from LivaNova. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
