FDA-Device2017-02-22Class II
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Advanced Sterilization Products
Hazard
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.
Sold states
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 Britain, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, Japan, Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Affected count
7,694 units total (5,935 units in US)
Manufactured in
33 Technology Dr, N/A, Irvine, CA, United States
Products
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2017Don't want to check this manually?
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