Koios DS Breast <series 1.0> recall — FDA Z-0820-2020
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Overview of recall records associated with Koios Medical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
This page summarizes recall records in which the official source identifies Koios Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.