Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 29, 2020
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedur…
Koios Medical, Inc. recalled Koios DS Breast <series 1.0>. The device is a software application which assists skilled … - a moderate-severity action.
Koios DS Breast <series 1.0>. The device is a software application which assists skilled … was recalled by Koios Medical, Inc. in January 29, 2020. Reason: Affected software product versions were found during internal audit to have been marketed for sale without su…. Check the official notice for the remedy. Verify recall #Z-0820-2020 with the FDA Devices before acting.
The recall
Koios Medical, Inc. issued this moderate-severity FDA Devices recall-Affected software product versions were found during internal audit to have been marketed for sale without su….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- January 29, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0820-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0820-2020) was formally reported on January 29, 2020, with the manufacturer initiating the action on December 31, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Koios Medical, Inc. is listed as the recalling firm, operating out of New York, NY. Federal records list the affected scope as 10.
The documented reason for this recall is: Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures. Distribution data in the federal record shows the product reached: Distributed to customers in NY, NJ, and MO.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product description
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0820-2020 |
| Date reported | January 29, 2020 |
| Date initiated | December 31, 2019 |
| Recalling firm | Koios Medical, Inc. |
| Firm location | New York, NY |
| Affected scope | 10 |
| Distribution | Distributed to customers in NY, NJ, and MO. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0820-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.. Recalled by Koios Medical, Inc.. Units affected: 10.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0820-2020.
Where was the recalled product distributed? ▼
Distribution: Distributed to customers in NY, NJ, and MO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0820-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 29, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.