Medical device manufacturer, Getinge, has issued a medical device safety alert concerning its Washer Disinfector CM320 [Affected Serial Number: 31244 – 31303, W50024942 – W50048716, WAA052208 – WAA096623].
It was discovered that a water inlet plastic hose connection may deform or break due to material fatigue or hose clamp overtightening. A broken hose connection can cause a water leakage and water spray. The potential water leakage from the hose connector is within the service area of the device, behind the cover sheet.
This potential for malfunction may be caused by incorrect choice of material when the machine was designed. Other contributors are that the hoses not always are supported and attached to the equipment and that the hose clamps are tightened too hard, which causes deformation and potentially cracks. The manufacturer has developed new hose connectors in stainless steel to replace the connectors in plastic.
According to the manufacturer, the device is still safe to use but be extra cautious for any water leaks and follow the instruction for daily maintenance. The manufacturer will provide a correction kit to affected users.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 23 December 2020