AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthc
FDA device recall Z-0915-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FLE
- Quantity affected
- 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,
- Date initiated
- 2013-02-12
- Date posted
- 2013-03-06
- Date terminated
- 2013-12-05
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMSCO CHIMERON MEDIUM STEAM STERLILZER (K112403) | STERIS Corporation | 2012-05-08 |
| AMSCO CHIMERON SMALL STEAM STERILIZER (K111223) | STERIS Corporation | 2011-09-20 |