Recall Z-0210-2016 ยท FLE Sterilizer, Steam
Steris Corporation
AMSCO 400 and AMSCO C Small Steam Sterilizers
| Date | Nov 4, 2015 (initiated Sep 3, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | On 9/21/2015 the firm sent Recall Correction Notices to their customers. |
| Quantity | 32 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111223 | AMSCO CHIMERON SMALL STEAM STERILIZER STERIS Corporation, Sep 20, 2011 |