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 |
|
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 |