Recall Z-1561-2015 ยท FLE Sterilizer, Steam
Steris Corporation
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.
| Date | Apr 30, 2015 (initiated Feb 19, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| Action | On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sal |
| Quantity | 701 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |