PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280;
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
System Product Name - UDI-DI Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890, Azurion 3M15 - 00884838085282, 00884838099210, Azurion 5M12 - 00884838099227, Azurion 5M20 - 00884838099234, Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265, Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883, Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890, Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890, Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276, Software Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
Products Sold
System Product Name - UDI-DI Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890; Azurion 3M15 - 00884838085282, 00884838099210; Azurion 5M12 - 00884838099227; Azurion 5M20 - 00884838099234; Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265; Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883; Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890; Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890; Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276; Software Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Num due to System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs du. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
Recommended Action
Per FDA guidance
On December 12, 2023, the firm notified customers via certified mailing of URGENT Medical Device Correction letters. Customers may identify affected products by the system product name and model number, which can be found on the System Identification Label located on the system stand. The software version of the Philips Azurion system can be identified during start-up. Customers were advised to keep the number of studies in the patient database as low as possible, but at least below 500. Customers should keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system. Ensure that all users of the system are notified of the issue. Philips is working on a software release that will correct this issue. Philips representatives will contact affected customers to schedule the correction. Please contact your local Philips representative for further information or support concerning this issue.
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