# FDA recall Z-0213-2022

> **Philips North America Llc** · Class II · device recall initiated 2021-09-24.

## Product

Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228.  (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

## Reason for recall

When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

## Distribution

Domestic distribution nationwide. International distribution worldwide.

## Key facts

- **Recall number:** Z-0213-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-24
- **Report date:** 2021-11-17
- **Termination date:** 2024-09-26

- **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-0213-2022

## Citation

> AI Analytics. FDA recall Z-0213-2022. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0213-2022. Source: US FDA. Licensed CC0.

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