Recall archive / FDA device enforcement
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7... — FDA record Z-0835-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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;
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 1,799 US; 5,747 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0835-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 7, 2024
- Recall initiation date
- Dec 12, 2023
- Center classification date
- Jan 26, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.