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;
This recall is currently active, issued January 26, 2024. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- December 12, 2023
- Posted
- January 26, 2024
- Recall Number
- Z-0835-2024
- Quantity
- 1,799 US; 5,747 OUS
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.