# FDA recall Z-0471-2022

> **Philips North America Llc** · Class II · device recall initiated 2021-11-12.

## Product

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue  Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

## Reason for recall

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

## Distribution

Worldwide distribution - US Nationwide distribution in the state of WA and the countries of  France, Germany, Japan, Poland, United Kingdom.

## Key facts

- **Recall number:** Z-0471-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-12
- **Report date:** 2022-01-19
- **Termination date:** 2024-02-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2022

## Citation

> AI Analytics. FDA recall Z-0471-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0471-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*