Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
FDA Recall Z-0820-2020 · Posted None
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Recalling FirmKoios Medical, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2019-12-31
Date Terminated2020-05-07
Product Quantity10
Reason for Recall
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Firm Action
On 12/31/19, the firm issued Urgent Medical Device Recall letters to affected customers. Customers were advised of the product recall. The firm stated that they would voluntarily and free of charge upgrade all affected customer installed versions with the most recently FDA-cleared product. The firm followed up with email notifications sent on 1/3/2020.
Root Cause
Other
Distribution Pattern
Distributed to customers in NY, NJ, and MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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