Device product
AMSCO 3000 Series Washer/Disinfector Model # 3052
Z-0995-2019
Product summary
- Event
- Event 82035
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-0995-2019
Official wording
Reason: 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.
Code information: Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software in the systems may not process the cycle originally intended. This could result in