Recall Z-1197-2017 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
| Date | Feb 14, 2017 (initiated Jan 9, 2017) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. |
| Root cause | Software design |
| Action | Advanced Sterilization will send an Field Safety Notice dated January 9, 2017,to inform customers that Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. ASP is sending the letter to remind customers to follow the instructions in the STERRAD NX System Users 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) pe |
| Quantity | 7,694 units total (5,935 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Australia, China, Hong Kong, India, Indonesia, Korea (South), Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam, Canada, Belgium, Czech Republic, Egypt, France, Germany, Great |
| FDA record | Open on fda.gov |