AMSCO 400 and AMSCO C Small Steam Sterilizers
FDA device recall Z-0210-2016 · posted 2015-11-04 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- 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.
- Action taken
- On 9/21/2015 the firm sent Recall Correction Notices to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FLE
- Quantity affected
- 32 units
- Distribution
- US nationwide distribution.
- Date initiated
- 2015-09-03
- Date posted
- 2015-11-04
- Date terminated
- 2016-01-22
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMSCO CHIMERON SMALL STEAM STERILIZER (K111223) | STERIS Corporation | 2011-09-20 |