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
Product summary
- 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
software in select AMSCO 400 and AMSCO C units will