Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26470 |
| Brand Name: | Heat Exchanger |
| Model: | |
| Affected: | Serial numbers - From 90032260 to 90032415 |
| 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: | Due to the update of the IEC Standard 60601-1-2 for Electromagnetic compatibility (EMC) to its 4th edition, the medical devices Heater Unit HU 35 and ROTAFLOW Console (standard and ICU version) of Maquet Cardiopulmonary GmbH/ GETINGE were updated accordingly. Therefore the related Instructions for Use (IFU) for these devices were amended with the corresponding new information regarding the applied EMC standard as well. All devices delivered with these IFUs fullfill the 4th edition of the IEC Standard 60601-1-2 for EMC. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/8/2020 |
