Reported Jun 10, 2026 · Ongoing
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 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 7B12/12
- Model Numbers722067, 722225 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)00884838099265(21)104(01)00884838085350(21)221(01)00884838099265(21)153(01)00884838099265(21)46(01)00884838099265(21)28(01)00884838085350(21)250(01)00884838099265(21)72(01)00884838099265(21)208(01)00884838099265(21)41(01)00884838099265(21)122(01)00884838099265(21)147(01)00884838085350(21)225(01)00884838099265(21)262(01)00884838099265(21)112(01)00884838099265(21)110(01)00884838099265(21)207(01)00884838099265(21)68(01)00884838099265(21)177(01)00884838099265(21)29(01)00884838099265(21)71(01)00884838099265(21)37(01)00884838099265(21)175(01)00884838099265(21)148(01)00884838099265(21)205(01)00884838099265(21)229(01)00884838099265(21)228(01)00884838085350(21)277(01)00884838085350(21)115(01)00884838099265(21)157(01)00884838085350(21)163(01)00884838099265(21)268(01)00884838085350(21)75(01)00884838085350(21)132(01)00884838085350(21)147(01)00884838085350(21)208(01)00884838085350(21)104(01)00884838085350(21)244(01)00884838085350(21)234(01)00884838099265(21)53(01)00884838099265(21)259(01)00884838099265(21)55(01)00884838099265(21)235(01)00884838099265(21)298(01)00884838085350(21)70(01)00884838099265(21)233(01)00884838099265(21)141(01)00884838099265(21)289(01)00884838099265(21)249(01)00884838099265(21)84(01)00884838099265(21)111(01)00884838099265(21)227
- Amount recalled
- 51 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.
Want the full recall guide?
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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