# FDA recall Z-0293-2021

> **Pentax of America Inc** · Class II · device recall initiated 2020-09-22.

## Product

9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

## Reason for recall

There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.

## Distribution

US Nationwide and Canada

## Key facts

- **Recall number:** Z-0293-2021
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-22
- **Report date:** 2020-11-04
- **Termination date:** 2022-05-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montvale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2021

## Citation

> AI Analytics. FDA recall Z-0293-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0293-2021. Source: US FDA. Licensed CC0.

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