Z-2476-2021Class II

The Azurion series (within the limits of the used Operation Room table) are intended for use to perform...

Name: Z-2476-2021 The Azurion series (within the limits of the used Operation Room table) are intended for use to perform...
Creator: Philips North America Llc
Published: 2021-08-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-08-13 / Terminated / root cause: design

FDA source

Philips North America Llc began a recall of The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and... on 2021-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2476-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-13
Posted: 2021-09-14
Terminated: 2024-03-11
Recalling firm: Philips North America LLC
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Action: Philips notified accounts by Urgent Medical Device Recall letter via certified mailing United States Postal Service (USPS) on 8/13/21. Letter states reason for recall, health risk and action to take: Please place this Medical Device Recall letter with the documentation of the system until this correction has been implemented in your system. Additionally, please return the attached reply form to Phhilps to confirm that the users of the system have reviewed and understood this Medical Device Recall. Philips will correct the affected systems by replacing the ADUs. A Philips service representative will contact you to schedule the correct ion of your system. Please be assured that maintaining a high level of safety and quality is our highest priority. lf you need any further information or support concerning thls issue, please contact your local Philips representative: 1-800-722-9377 (reference FCO72200483
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the states of ID, MA, MI, TX, VA.
Product codes and lots: Serial number: 921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2476-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2474-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-14
Z-2475-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-14
Z-2476-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-14

Product code OWB

K162148Class IIAllura Xper R9Philips Medical Systems Nethrlands BV / cleared 2016-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)