# FDA recall Z-0070-2021

> **Devicor Medical Products Inc** · Class III · device recall initiated 2020-09-07.

## Product

Neoprobe GDS Control Unit, Model Number NPCU3

## Reason for recall

It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.

## Distribution

The products were distributed only to China.

## Key facts

- **Recall number:** Z-0070-2021
- **Recalling firm:** Devicor Medical Products Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-07
- **Report date:** 2020-10-14
- **Termination date:** 2023-05-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2021

## Citation

> AI Analytics. FDA recall Z-0070-2021. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0070-2021. Source: US FDA. Licensed CC0.

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