FDA-Device2015-11-11Class III
AMSCO 400 and AMSCO C Small Steam Sterilizers
Steris Corporation
Hazard
In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.
Sold states
US nationwide distribution.
Affected count
32 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
AMSCO 400 and AMSCO C Small Steam Sterilizers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2016Don't want to check this manually?
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