FDA-Device2019-03-20Class II

AMSCO 3000 Series Washer/Disinfector Model # 3052

Hazard

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.

Sold states
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.
Affected count
11
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
AMSCO 3000 Series Washer/Disinfector Model # 3052

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2019

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