AMSCO 3000 Series Washer/Disinfector Model # 3052
- Company
- Steris Corporation
- Recall Initiated
- December 20, 2018
- Terminated
- July 22, 2019
- Recall Number
- Z-0995-2019
- Quantity
- 11
- Firm Location
- Mentor, OH
Reason for Recall
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
Distribution
The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
Lot / Code Info
Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
Root Cause
Software Manufacturing/Software Deployment
Action Taken
Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.