# FDA recall Z-2476-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-08-13.

## Product

The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:  "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.  "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.  Additionally:  "The Azurion series can be used in a hybrid Operation Room.  "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

## Reason for recall

Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU.     The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails.    When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.

## Distribution

US Nationwide distribution in the states of ID, MA, MI, TX, VA.

## Key facts

- **Recall number:** Z-2476-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-13
- **Report date:** 2021-09-22
- **Termination date:** 2024-03-11

- **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-2476-2021

## Citation

> AI Analytics. FDA recall Z-2476-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2476-2021. Source: US FDA. Licensed CC0.

---

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