Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19774
Brand Name:Draeger Babylog VN500 Ventilator
Model:
Affected: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:
Affected: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 300 with optional PS500
Model:
Affected: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:Manufacturer has become aware of cases in which the battery capacity of the optional PS500 power supply unit for the Evita Infinity V500, Evita Infinity V300 and the Babylog VN500 was rapidly and unexpectedly reduced despite using the most recent power supply firmware (FW1 .50) which was released in November 2015. The batteries prematurely discharged, even though an adequate battery charge status was displayed on the device. The "Battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. When the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. Given these new findings, the decision has been made to cancel the distribution of the updated power supply firmware (FW1.50) and to roll back devices on which this firmware version is already installed to FW1.49.
Recall action type:Correction
Recall action:Product to be exchanged
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:19/2/2016
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