AMSCO 3000 Series Washer/Disinfector Model # 3052
FDA Recall Z-0995-2019 · Posted None
Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMEC
Date Initiated2018-12-20
Date Terminated2019-07-22
Product Quantity11
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.
Firm Action
Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
Root Cause
Software Manufacturing/Software Deployment
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.