Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29411 |
| Brand Name: | Heater Cooler Unit |
| Model: | All HU35, 230 V devices serial number 90039999 |
| Affected: | |
| 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: | Update 15 September 2023: The manufacturer has identified and qualified a new resistant replacement material. However, the implementation of this material is still pending due to missing regulatory approval by the Notified Body. When the approval is given, the material will be implemented as soon as possible. Until this time, the corrective measures of this action remain active. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/9/2023 |
