Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26433 |
| Brand Name: | Heater Cooler Unit |
| Model: | |
| Affected: | All HCU 40 units below S/N: 90442012 |
| Software version: | |
| Recalling Organisation: | Getinge Australia Pty Ltd (NZ) Unit D, Ground Floor, Building A, Millenium Centre 600 Great South Rd Ellerslie Auckland 1051 |
| Contact Information: | 09 272 9039 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Issue: | On 17th August 2020, the manufacturer issued Medsafe# 26433 to replace existing vacuum valves of the HCU 40 Heater-Cooler Unit by a new successor component in all HCU 40 systems serial number 90442012. Despite intensive verification testing before releasing this new vacuum valve type Romer for production and spare part supply, complaints were received for this component in HCU 40 systems in the field, indicating a significantly higher probability of failure than for the predecessor vacuum valve type. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/2/2021 |
