# FDA recall Z-2073-2020

> **Capso Vision, Inc.** · Class II · device recall initiated 2019-07-03.

## Product

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

## Reason for recall

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

## Distribution

US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.

## Key facts

- **Recall number:** Z-2073-2020
- **Recalling firm:** Capso Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-03
- **Report date:** 2020-05-27
- **Termination date:** 2021-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saratoga, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2073-2020

## Citation

> AI Analytics. FDA recall Z-2073-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2073-2020. Source: US FDA. Licensed CC0.

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