As part of the company's post market surveillance, they have identified an issue related to the safe usage of the HistoCore Arcadia H system. The problem is associated with the sealing of the paraffin tank. The process of paraffin solidification in the paraffin tank may lead to the deformation of the tank. This in turn, may cause the sealing of the tank to tear. Subsequent overfilling of the paraffin can cause the excess of melted paraffin to flow into the housing of the HistoCore Arcadia H. The paraffin can then soak into the insulation material. This may cause the saturated insulation material to fall onto the printed circuit board assembly and primary circuit. Because the paraffin-saturated insulation material no longer retains its flame resistance properties, this may lead to the development of toxic smoke and an internal fire in the HistoCore Arcadia H. Instruments manufactured after April 2017 do already have a reinforced tank which avoids any bending. Recall start date: May 2, 2024
RecallTracker