Recall company profile

Koios Medical, Inc. Recalls

Overview of recall records associated with Koios Medical, Inc., including dates, categories and classifications where available.

1recall records
Jan 29, 2020latest record date
Jan 29, 2020earliest record date

Recall history in this database

Classification mix: Class II: 1.

Medical DeviceJan 29, 2020

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.

Class IIFDA: TerminatedKoios Medical, Inc.

Understanding this recall history

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.