Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20911 |
| Brand Name: | Getinge Group Heater Cooler Unit |
| Model: | |
| Affected: | Part Numbers: HU35 |
| Software version: | |
| Recalling Organisation: | Maquet Australia Pty Ltd (NZ) 12G Andromeda Cres East Tamaki Auckland 2013 |
| Contact Information: | 021 874 882 |
| Manufacturer: | Maquet Cardio Pulmonary GmbH |
| Issue: | Investigations have confirmed that the current published disinfection procedure of the HU 35 system's water paths (in the Instructions for Use) does not adequately meet contemporary hygienic requirements and effectiveness against atypical mycobacteria. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/12/2016 |
