Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24308
Brand Name:Infinity Acute Care System Monitoring - M540
Model:
Affected:with sw VG7.0.1
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:INFINITY Patient Monitors & Accessories
Model:
Affected:with sw VG7.0.1
Software version:
Recalling Organisation:Draeger New Zealand Ltd
Unit 4
24 Bishop Dunn Place
East Tamaki
Auckland 2013
Contact Information:0800 559 186
Manufacturer:Draeger Medical Systems Inc
Issue:The manufacturer has identified that when the ECG cable plug is not properly connected, the Infinity M540 Patient Monitor may reboot. If the situation is not corrected and the reboot occurs 3 times in 10 minutes or less, the Infinity M540 Patient Monitor will enter a fail-state, resulting in a resetting to factory defaults, losing patient settings and locally stored patient data. The reboot and the fail state are indicated by visual and audio alarms.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:14/3/2019
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