Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19463 |
| Brand Name: | Draeger Babylog VN500 Ventilator with optional PS500 |
| Model: | VN500 |
| Affected: | With optional PS500 installed |
| 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 |
| Brand Name: | Draeger Infinity V500 with optional PS500 |
| Model: | Infinity V500 |
| Affected: | With optional PS500 installed |
| 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 |
| Brand Name: | Draeger Evita V300 with optional PS500 |
| Model: | Evita V300 |
| Affected: | With optional PS500 installed |
| 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: | Draeger has become aware of cases in which the battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500, Evita V300 and Babylog VN500 ventilators) was unexpectedly shortened. The batteries were discharged early, even though the device was indicating an adequate battery state of charge. The devices generate a "Battery Low" alarm, followed by "Battery Flat". In exceptional cases, the "Battery Flat" alarm might be displayed too late, or not at all. After complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases. Current analysis of the battery data available indicates that an operating time of at least 20 minutes can normally be maintained after the device is disconnected from the power supply, which sufficiently bridges the gap in the event of a mains power failure until the emergency power supply can be activated. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/11/2015 |
