Important Safety Alerts

Medical device manufacturer, Philips Medical Systems, has issued a medical device safety alert concerning TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI LXL, GEMINI TF 16, GEMINI TF 64 and GEMINI TF Big Bore.

The TumorLOC application has the capability to generate intensity projection datasets from respiratory gated data. A circumstance has been identified where these generated datasets are flipped and incorrectly labeled left to right when they are saved to disk.

This problem occurs only if all of the following circumstances are met:

1. The Respiratory Gated series are loaded into TumorLOC along with a non-gated (Free Breathing) series, and
2. The data loaded into TumorLOC is generated with specific Patient Orientations, and reconstructed with specific View Conventions (See below).

• Head First Prone / Right on Left
• Head First Prone / View from Feet
• Feet First Supine / View from Bed
• Feet First Prone / View from Feet

If the flipped intensity Projection dataset is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.

The manufacturer advised the affected users to maintain a copy of the field safety notice(FSN) with the equipment instructions for use and follow the additional instructions mentioned in the FSN until the software correction is issued.

According to the local supplier, the affected devices were distributed in Hong Kong.

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

Posted on 13 November 2012