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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01234-1
Product Name/Description Corpuls Defibrillator (Automated defibrillator). Software version 2.0.0 and 2.0.2

ARTG Number: 192745
Recall Action Level Retail
Recall Action Classification Class I
Recall Action Commencement Date 7/12/2012
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue Due to a malfunction of the software, the display on the monitoring unit may sporadically freeze and stop being operable, after a diagnostic ECG has been started. The error manifests as extremely slow curve build-up or lack of curves in the D-ECG preview. In this condition, the device no longer reacts to keys being pressed.
Recall Action Recall for Product Correction
Recall Action Instructions As an interim measure, the sponsor is providing work around instructions to reduce the probability of occurrence. A software update will be installed to permanently correct the issue as soon as possible.
Contact Information 1800 429 551 - Device Technologies