Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22901 |
| Brand Name: | Therapeutic plasma exchange system |
| Model: | 955052, 114870, 114489, 107493, 113082 and 113874 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| Contact Information: | 0800 229 837 |
| Manufacturer: | Gambro Lundia AB |
| Issue: | Manufacturer has identified that all Prismaflex Control Units exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Manufacturer will be releasing new firmware that will prevent the malfunction from occurring |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/5/2018 |
