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Recall Observatory FDA recall evidence

Device product

AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

Z-1561-2015

February 19, 2015

Class II

Product summary

Firm
Steris Corporation
Event
Event 70938
Status
Terminated
Classification
Class II
Quantity
701 units
Official record key
device-enforcement:Z-1561-2015

Official wording

Reason: STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.

Code information: AMSCO 400 Units: Serial #'s: 030051501 - 033641440; AMSCO C Units: Serial #'s: R020051501 - R023641403.

Distribution pattern: Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of Afghanistan, Canada, Japan, Kuwait, Mexico, Republic of Korea, & United Arab Emirates.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software in select AMSCO 400 and AMSCO C units will