STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA device recall Z-1197-2017 · posted 2017-02-14 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- 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.
- Action taken
- 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) per the Users Guide. Customers are instructed to complete and return the attached Business Reply Card (double-sided) for their acknowledgement within 3 business days of receipt of this notification letter via mail by using the pre-paid postage, by email at ASP5816@stericycle.com, or by fax to Stericycle: 8662297775. For questions regarding the business reply card, customers are instructed to contact Stericycle at (877) 497- 2425 and reference event # 5816. For further questions regarding this recall please call (949) 453-6400,
- Root cause
- Software design
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 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, S
- Date initiated
- 2017-01-09
- Date posted
- 2017-02-14
- Date terminated
- 2017-11-02
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K151725) | Advanced Sterilization Products | 2016-01-13 |
| STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K142454) | Advanced Sterilization Products | 2015-04-03 |
| STERRAD NX STERILIZER (K042116) | Advanced Sterilization Products | 2005-04-22 |