CuattroDR System Software — Class II medical device recall Z-1934-2020
Terminated recall by Cuattro LLC, reported 2020-05-20, distributed in AR, MI, NC, NJ, SC. There is a potential that an image from a previous patient study to show up in a later patient study. This may
| Recall number | Z-1934-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cuattro LLC, Golden, CO, United States |
| Recall initiated | 2019-10-15 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-04-27 |
| Distributed | AR, MI, NC, NJ, SC |
| Quantity | 9 units |
| Model numbers | SWR-00069-MD |
Product
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Reason for recall
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1934-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.