Health Canada — Medical Devices · Canada · 2019-08-16 · Type II
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Reported risk: The affected HU 35 heater unit(s) might have been delivered with an incorrect software version - not in correspondence with the set point temperature range described in the instructions for use. The affected units potentially have received the software version 1.01 Instead of the correct software version 1.02.In version 1.01 Of the HU 35 software, the set point water temperature can be set between 33°C and 39°C, while in the correct software version 1.02 For the set point temperature range is limited between 35°C and 39°C. Furthermore in software version 1.01 A high priority alarm (visual and acoustic alarm) is triggered if the water temperature falls to 32°C or below while in the new correct software version 1.02 A high priority alarm is already triggered if the water temperature drops to 34°C or below in order to avoid unintended hypothermia of a patient connected.
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