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Recall Observatory FDA recall evidence

Device product

AMSCO 3000 Series Washer/Disinfector Model # 3052

Z-0995-2019

December 20, 2018

Class II

Product summary

Firm
Steris Corporation
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

    reason.device_software_design · v1.0.0

    software in the systems may not process the cycle originally intended. This could result in