Recall Z-0073-2024— LivaNova Deutschland GmbH

Name: FDA recall Z-0073-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-03

Class II · Ongoing

Class II FDA medical device recall by LivaNova Deutschland GmbH, initiated 2023-08-03. It names one FDA 510(k) clearance: K191402. Product: 3T Heater Cooler System, REF: 16-02-85. Reason: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device..

Recalling firm: LivaNova Deutschland GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-08-03
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K191402 — Heater-Cooler System 3TLivanova Deutschland, GmbH·cleared 2020-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

3T Heater Cooler System, REF: 16-02-85

Reason for recall

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.