# FDA recall Z-1934-2020

> **Cuattro LLC** · Class II · device recall initiated 2019-10-15.

## 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.

## Distribution

US: NJ, MI, SC, NC, MI, AR,   OUS: None

## Key facts

- **Recall number:** Z-1934-2020
- **Recalling firm:** Cuattro LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-15
- **Report date:** 2020-05-20
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Golden, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2020

## Citation

> AI Analytics. FDA recall Z-1934-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1934-2020. Source: US FDA. Licensed CC0.

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