Important Safety Alerts

Medical device manufacturer, Volcano, has issued a field safety notice concerning its s5/s5i/CORE/CORE Mobile systems. The affected software versions are v3.2.x, v3.3 and v3.4.

The manufacturer has become aware of a system incompatibility issue between the affected systems and hospital network scans. In specific circumstances, the affected system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. This condition can occur at any time, including in the middle of a patient procedure. If this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of IVUS and FFR/iFR functionality in the procedure.

The manufacturer advises users of the following:

• Disconnect the affected system from the facilities network. If users need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; or
• Do not perform network scans while the affected system is in operation.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 10 May 2016