CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
Koios DS Breast <series 0>. The device is recalled by Koios Medical
Koios Medical is recalling Koios DS Breast <series 0>. The device is a, distributed in Missouri, New Jersey, New York. The recall was initiated on 31 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0820-2020
- FDA event ID
- 84615
- Recalling firm
- Koios Medical, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Dec 2019
- FDA classified
- 17 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 31 Dec 2019 | Recall initiated by company | |
| 17 Jan 2020 | Classified by FDA | +17 days |
| 29 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Where it was distributed
Distributed to customers in NY, NJ, and MO.
Questions about this recall
Is Koios DS Breast <series 0>. The device is a recalled?
Yes. Koios Medical recalled Koios DS Breast <series 0>. The device is a on 31 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0820-2020.
Why was it recalled?
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Which lots are affected?
Models/Versions: 1.2.df61abccd836; 1.2.576fd5569198; 1.3.51a5fadf18dd; 1.3.1.b5c53f1fc08d; 1.3.1.694531bfb9c7; 1.3.1.aaffb0cc2485; 1.3.2.6a67eb8088ed; 1.4.a7e352273dd6; 1.6.1.1*; 1.6.2.1* *Note: versioning scheme was modified to encompass the Build/Commit Number into a fourth digit with the development of version 1.5 (which was never distributed).
Where was it sold?
Distributed to customers in NY, NJ, and MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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