Reported Jan 28, 2026 · Ongoing
Philips Azurion system; Software Version Number: R3.1;
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
- Philips Azurion system
- Software Version NumberR3.1
- Lot codes and dates
57 of 57 products
Products covered by this recall Model / number Barcodes Product as published — Software Version Number: R3.1 722221(1) — System Product Name: Azurion 3 M12 — 00884838099203UDI-DI: 00884838099203 722222Serial Numbers: (2) — System Product Name: Azurion 3 M15 — 00884838099210UDI-DI: 00884838099210 722223Serial Numbers: (3) — System Product Name: Azurion 7 M12 — 00884838099241UDI-DI: 00884838099241 722224Serial Numbers: (4) — System Product Name: Azurion 7 M20 — 00884838099258UDI-DI: 00884838099258 722225Serial Numbers: (5) — System Product Name: Azurion 7 B12 — 00884838099265UDI-DI: 00884838099265 722226Serial Numbers: (6) — System Product Name: Azurion 7 B20 — 00884838099272UDI-DI: 00884838099272 722227Serial Numbers: (7) - Amount recalled
- 228 units (all OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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