Medical Device Safety Alert: CooperSurgical Wallach LL100 Cryosurgical System
The manufacturer's internal quality assurance programme has determined that one of the internal gas lines may malfunction causing the line to burst under pressure.
According to the manufacturer, the potential hazard associated with the failure mode is negligible; there is no foreseen adverse event due to this failure mode.
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 25 March 2015