Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23604 |
| Brand Name: | Stryker Medical - IIb - 36956 - Circulating-fluid whole-body heating/cooling system control unit |
| Model: | |
| Affected: | Altrix model 8001 units manufactured between October 4, 2016 and June 30, 2017 |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | Stryker Medical |
| Issue: | The manufacture has identified hazards associated with the Altrix model 8001 units: 1. Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5 C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms. 3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/9/2018 |
