FDA Device recall Z-0210-2016
AMSCO 400 and AMSCO C Small Steam Sterilizers
- FDA Device
- Class III
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class III recall of AMSCO 400 and AMSCO C Small Steam Sterilizers by Steris, citing 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 Operato….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0210-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-03 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | US |
Product
AMSCO 400 and AMSCO C Small Steam Sterilizers
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.
Identifiers
| code_info | Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 0323413…Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2016%22
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