Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Ingenia 1.5T, Ingenia 1.5T (S), Ingenia 1.5T CX, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Smartpath to dStream 1.5T and Smartpath to dStream for XR and 3.0T.
The manufacturer is informing users of a problem that the tabletop of the abovementioned devices could not fully move in (or out) when using manual mode , and if it were to re-occur, will pose a risk for patients or users. The horizontal tabletop movement can be either motorized or in manual mode. Manual mode means that the tabletop is moved manually by pushing or pulling the tabletop handgrip by the operator. When the horizontal movement is in manual mode, the tabletop outward motion may be blocked while the table is only partly out of the bore. This is due to a mechanical failure (wrong gear profile).
According to the manufacturer, an unacceptable hazardous situation can occur, when the tabletop is in 'manual' mode during a quick evacuation of the patient from the Magnetic Resonance or MR system. Motorized movement, using the tumble switch at the User Interface Module (UIM), is functional, because the point of engagement of the retraction force is different with respect to manual movement.
According to the local supplier, the affected products are distributed in Hong Kong. The manufacturer is instructing users to perform a quick check of the manual table movement of their MR systems. In case of any doubts, or further information or support concerning the abovementioned issue, please contact your supplier for necessary action.
Posted on 3 May 2021