Medical device manufacturer, Advanced Sterilization Products, has issued a medical device safety alert concerning its STERRAD NX System [Part number: 10033, 10033-022].
The manufacturer has identified that in a rare sequence of events following an external power outage, the system door interlock can become disengaged during system reboot for a 20-second duration. The manufacturer is sending this medical device safety alert to remind customers to follow the instructions in the STERRAD NX System User's Guide. Specifically, after cycle initiation, the user should only open the chamber door of the STERRAD NX System when prompted by the Graphical User Interface (GUI) per the User's Guide.
The manufacturer advises users to follow the instructions in the User's Guide, Chapter 5 for normal operation. Specifically, after cycle initiation, the user should only open the chamber door of the STERRAD NX System when prompted by the GUI per the User's Guide.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 January 2017