Reported Jun 10, 2026 · Ongoing
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6…
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 6 · Best · N/A
Is this the product you have?
- Philips Azurion 3M15
- Model Numbers722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
- Lot codes and dates
UDI (01)00884838085282(21)209(01)00884838099210(21)100(01)00884838099210(21)254(01)00884838099210(21)256(01)00884838099210(21)257(01)00884838099210(21)265(01)00884838099210(21)255(01)00884838099210(21)99(01)00884838085282(21)260(01)00884838085282(21)261(01)00884838099210(21)69(01)00884838099210(21)12(01)00884838085282(21)314(01)00884838085282(21)259(01)00884838099210(21)15(01)00884838099210(21)19(01)00884838099210(21)23(01)00884838099210(21)17(01)00884838085282(21)258(01)00884838099210(21)55(01)00884838099210(21)45(01)00884838085282(21)270(01)00884838099210(21)187(01)00884838099210(21)223(01)00884838099210(21)44(01)00884838099210(21)113(01)00884838099210(21)112
- Amount recalled
- 27 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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