Recall Z-0073-2024 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
LivaNova Deutschland GmbH
3T Heater Cooler System, REF: 16-02-85
| Date | Oct 6, 2023 (initiated Aug 3, 2023) |
| Status | Open, Classified |
| Reason | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. |
| Root cause | Labeling Change Control |
| Action | On August 3, 2023 and August 28, 2023, LivaNova issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. LivaNova asked consignees to take the following actions: With the help of Attachment 1 of this letter, identify the location of the 3T Heater- Cooler device(s) where there may be an incorrect QRG. 2. Dispose of only the Quick Reference Guide rev 22 (bound of laminated pages). A new copy of the quick reference guide will be delivered to your facility as soon as possible. 3. Check whether the maintenance schedule reported in OI section 6.2.1 was followed. A |
| Quantity | 37 systems |
| Distribution | US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191402 | Heater-Cooler System 3T Livanova Deutschland, GmbH, Feb 25, 2020 |