Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23753 |
| Brand Name: | LivaNova Heater Cooler |
| Model: | Heater-Cooler 3T, 230V |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | LivaNova Deutschland GmbH |
| Issue: | The manufacturer is advising all 3T Heater Cooler users that following the current version of the cleaning instructions within the Instruction for Use (IFU). Additionally, the manufacturer is providing all 3T Heater Cooler users with updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/10/2018 |
