# FDA recall Z-0727-2021

> **PHILIPS HOME HEALTHCARE SOLUTION** · Class II · device recall initiated 2020-12-08.

## Product

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

## Reason for recall

After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0727-2021
- **Recalling firm:** PHILIPS HOME HEALTHCARE SOLUTION
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-08
- **Report date:** 2021-02-03
- **Termination date:** 2024-06-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2021

## Citation

> AI Analytics. FDA recall Z-0727-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0727-2021. Source: US FDA. Licensed CC0.

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