# FDA recall Z-1145-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2024-01-02.

## Product

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.    Affected PCs: FlexViewing PC    Azurion Model Name - Model Number:    Azurion 7 B12  722067;  Azurion 7 B20  722068;  Azurion 7 M12  722078  722223;  Azurion 7 M20  722079;

## Reason for recall

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1145-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-02
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2024

## Citation

> AI Analytics. FDA recall Z-1145-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1145-2024. Source: US FDA. Licensed CC0.

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