The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2476-2021·Announced 2021-09-22

Philips Azurion Imaging System Failure at 480V Hospital Power Supply

Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device used in critical interventional procedures. While no injuries or illnesses have been reported, the documented failure mechanism creates a risk of harm by reducing imaging capability during critical medical procedures where reliable image guidance is essential.

Plain-English summary

Philips North America is recalling specific units of its Azurion series medical imaging system used for diagnostic and interventional guidance in operating rooms. The affected devices may experience early failure when hospital electrical mains provide 480V power. When this voltage is supplied, the coils that protect the insulated-gate bipolar transistors (IGBTs) in the Azurion Display Unit (ADU) can saturate and overheat. Some operators may notice a burning smell before the device fails.

When an ADU fails under these conditions, the system's X-ray performance is reduced to Emergency Fluoroscopy mode only. In this reduced mode, X-ray exposure is not possible and image quality is reduced.

Facilities using the Azurion system should verify their electrical power supply. If the system is operating with 480V mains power, contact Philips North America for guidance on this recall.

The recalled product

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…
Manufacturer
Philips North America Llc
Category
Medical Device — Imaging Equipment / Fluoroscopy System
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial number: 921

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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