CU Medical Systems is initiating a recall because the update provided as part of a previous corrective action (MHRA Ref.: 2021/002/001/601/002), did not satisfactorily solve the issue.
CU Medical Systems has identified an issue with the battery meter on a specific batch of the CU-SP1 AED (Automated External Defibrillator) that may cause the battery level indicator to show a lower value than the true value.
Please download this document for more information.
The cause of the issue has been identified and a fix is available via an re-install. This software re-install will be done by a trained engineer at no cost to the customer.
If you have one of the affected devices, please visit the following site to arrange your software update:
CU Medical would like to apologise to every affected customer and assure you that we will be correcting all affected devices.