Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22629
Brand Name:Infinity Acute Care System Monitoring - M540
Model:All released software versions (from VG2.2 to VG6.0)
Affected:
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:All released software versions (from VG2.2 to VG6.0);
Affected:
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 determined that when the Infinity M540 patient monitor is placed in Standby mode and the user simultaneously connects the Infinity MCable- Dual Hemo or Infinity MPod - Quad Hemo to the Infinity M540 patient monitor and then proceeds to zero the invasive pressure channel, in rare cases the invasive pressure visual and audible alarms are not activated.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:19/2/2018
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