Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28636 |
| Brand Name: | BabyLeo TN500 Incuwearmer |
| Model: | |
| Affected: | Drager Babyleo TN500 IncuWarmer installed with software lower than 1.06.00 |
| Software version: | |
| Recalling Organisation: | Draeger New Zealand Ltd Unit 4 24 Bishop Dunn Place East Tamaki Auckland 2013 |
| Contact Information: | 0800 559 186 |
| Manufacturer: | Draegerwerk AG & Co KGaA |
| Issue: | The manufacturer has identied that devices equipped with the Auto-Thermo Package, the Weaning procedure helps to automatically reduce the air temperature in a certain time interval defined according to the hospital protocol to wean patients from the incubator to an open care device. In recent software versions, the weaning function was stopped when Kangaroo Mode was activated. Consequently, the workflow was interrupted, and the weaning procedure on Babyleo TN500 had to be started again. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/11/2021 |
