Philips North America Llc 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 se Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 se
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Serial number: 921
Products Sold
Serial number: 921
Philips North America Llc is recalling The Azurion series (within the limits of the used Operation Room table) are intended for use to perf due to 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 overhea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026