Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its Brilliance 64 and Ingenuity computed tomography (CT) scanners. The affected CT systems are Brilliance 64, Ingenuity CT, Ingenuity Core and Ingenuity Core128. Only systems with the following versions are affected:
According to the manufacturer, some scans unexpectedly set the Axial (Z axis) scan length to a greater length than the user set in the plan. The issue occurs only when the following three conditions are met:
There is a potential for undesired radiation to areas not intended to be scanned.
The manufacturer is not recommending users to stop using the equipment. To eliminate the possibility of the defect from occurring, users are advised to eliminate any one of the three conditions mentioned above which is needed to trigger the behaviour. The manufacturer is developing a new version of software to eliminate the defect.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 August 2015