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Terminated

AMSCO 400 and AMSCO C Small Steam Sterilizers

FDA Recall Z-0210-2016 · Posted 2015-11-04

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFLE
Date Initiated2015-09-03
Date Terminated2016-01-22
Product Quantity32 units

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.

Firm Action

On 9/21/2015 the firm sent Recall Correction Notices to their customers.

Root Cause

Software design

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111223AMSCO CHIMERON SMALL STEAM STERILIZERSTERIS Corporation · 2011-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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