Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15655
Brand Name:Draeger Infinity Acute Care System (IACS) in Neonatal Mode
Model:
Affected:
Software version:VG2.03 & higher
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 determined that a low SpO2 (yellow) medium grade alarm which is pased by the user using teh alarm pause function, may cause the central station monitoring the device not to alarm if the SpO2 level drops to high grade life threatening (red) alarm. The device itself will alarm.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:21/11/2013
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