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Recall Observatory FDA recall evidence

Device product

AMSCO 400 and AMSCO C Small Steam Sterilizers

Z-0210-2016

September 03, 2015

Class III

Product summary

Firm
Steris Corporation
Event
Event 72217
Status
Terminated
Classification
Class III
Quantity
32 units
Official record key
device-enforcement:Z-0210-2016

Official wording

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.

Code information: 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

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software inadvertently prevents