Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25851 |
| Brand Name: | Haemodialysis system - Lundia AB |
| Model: | |
| Affected: | upgrade to version 3 |
| Software version: | |
| Recalling Organisation: | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| Contact Information: | 0800 229 837 |
| Manufacturer: | Gambro Lundia AB |
| Issue: | On September 3, 2018, the manufacturer issued the enclosed Urgent Recall for Product Correction communication (Medsafe Ref #23537) regarding the potential for AK 98 Hemodialysis Devices to generate excessive ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. The manufacturer released software version V3.0 for the AK 98 device that mitigates cases of excessive fluid loss in patients. The manufacturer is in the process of upgrading all AK 98 devices to software version V3.0. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/3/2020 |
