# FDA recall Z-3023-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2019-11-20.

## Product

ProxiDiagnost N90

## Reason for recall

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

## Distribution

United States

## Key facts

- **Recall number:** Z-3023-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-20
- **Report date:** 2020-10-07
- **Termination date:** 2024-04-04

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3023-2020

## Citation

> AI Analytics. FDA recall Z-3023-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-3023-2020. Source: US FDA. Licensed CC0.

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