Philips North America Llc: Medical Device Recall in 2021 - (Recall #: Z-2476-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 13, 2021

Date Posted: September 22, 2021

Recall Number: Z-2476-2021

Event ID: 88546

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.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial number: 921

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated