# FDA recall Z-0835-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2023-12-12.

## Product

Philips Azurion system, Interventional fluoroscopic x-ray system.    System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 -  722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280;

## Reason for recall

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0835-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-12
- **Report date:** 2024-02-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2024

## Citation

> AI Analytics. FDA recall Z-0835-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0835-2024. Source: US FDA. Licensed CC0.

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