Important Safety Alerts

The Therapeutic Goods Administration (TGA), Australia posted a medical device safety alert concerning Philips Ingenuity Core [Model Number: 728321; Serial Number: 333175].

The manufacturer has identified systems that may have been infected with the "Wannacry" ransomware virus before installation. The virus may encrypt files in a way that:

• prevents system access; or
• a patient undergoing a scan or recently scanned whose results have not been reviewed may require a CT rescan; or
• during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real time.

According to the manufacturer, there have been no reports of patient harm as a result of this issue.

The manufacturer will contact the users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems

For details, please visit the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1

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

Posted on 16 April 2018