Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24966
Brand Name:Heat Exchanger
Model:
Affected:Distribution date: September, 2017 until October, 2018
Software version:
Recalling Organisation:Getinge Australia Pty Ltd (NZ)
Unit D, Ground Floor, Building A, Millenium Centre
600 Great South Rd
Ellerslie
Auckland 1051
Contact Information:09 272 9039
Manufacturer:Maquet Cardio Pulmonary GmbH
Issue:The manufacturer has determined that HU 35 Heater Units produced within the timeframe September, 2017 until October, 2018 might have been delivered with an incorrect software version - not in correspondence with the set point temperature range described in the Instructions for Use for these devices.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:7/8/2019
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