Medical device manufacturer, Chalice Medical Ltd, issued a medical device safety alert concerning its ParaTherm Heater/ Cooler [Product Codes: 54-00-16, 54-0018; All Serial Numbers].
The manufacturer is informing users that the colour of the LED which is used to optically signal an alarm condition is to be changed from red to yellow.
According to the manufacturer, this medical device safety alert does not result from any safety issues with the ParaTherm, but results from the alarm classification within the device being downgraded to meet the requirements of BS EN 60601-1-8. The alarm priority for the ParaTherm has changed from high priority to medium following the criteria in BS EN 60601-1-8 and has been evaluated fully as part of the manufacturer’s risk management activities. To meet the requirements of a medium priority alarm in compliance with the BS EN 60601-1-8 the visual alarm indicator must be yellow which has resulted in our LED changing from red to yellow. The manufacturer still considers the ParaTherm is safe to use until its scheduled service date.
The manufacturer has implemented an update to the ParaTherm IFU to change the information from red to yellow. ParaTherm units in the field, will be required to have the LED light changed during the next service. The manufacturer is instructing affected users that ParaTherm units should be sent for servicing as per the normal scheduling.
According to the manufacturer, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Sep 2021