FDA Medical devices recall ·
Philips Azurion system recall
- Recall number
- Z-1113-2026
- Date
- (initiated December 12, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 228 units (all OUS)
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips Azurion system; Software Version Number: R3.1;
Why was it recalled?
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers: (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers: (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers: (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers: (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers: (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers: (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers: (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers: (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33; (10) Model Number: 722230; System Product Name: Azurion 3 M15; UDI-DI: 00884838116733; Serial Numbers: 25, 54, 50, 52, 55, 30, 63, 60, 67; (11) Model Number: 722231; System Product Name: Azurion 5 M12; UDI-DI: 00884838116740; Serial Numbers: 62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18; (12) Model Number: 722232; System Product Name: Azurion 5 M20; UDI-DI: 00884838116757; Serial Numbers: 97, 39, 31, 100, 104, 93, 115, 113, 118, 119, 89, 54, 67, 7, 128, 86, 110, 132, 130, 131, 123, 137,
Distribution
International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;
States: Arkansas Arizona Colorado Delaware Idaho Illinois Indiana Massachusetts Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1113-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.