Recall Z-0915-2013 ยท FLE Sterilizer, Steam
Steris Corporation
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
| Date | Mar 6, 2013 (initiated Feb 12, 2013) |
| Status | Terminated |
| Reason | The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance. |
| Root cause | Software design |
| Action | Steris Corporation initiated their recall on February 12, 2013. They will notify customers via onsite visits by STERIS Field Service Technicians to each affected Customer site. For further questions, please call (440) 392-7601. |
| Quantity | 395 Units |
| Distribution | Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV. |
| FDA record | Open on fda.gov |