Reported Jun 10, 2026 · Ongoing
Philips Azurion 7M20, Model Numbers: 722079, 722224 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 7M20
- Model Numbers722079, 722224 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)00884838099258(21)450(01)00884838099258(21)750(01)00884838099258(21)409(01)00884838099258(21)262(01)00884838099258(21)275(01)00884838099258(21)277(01)00884838099258(21)295(01)00884838099258(21)272(01)00884838099258(21)261(01)00884838099258(21)630(01)00884838099258(21)1003(01)00884838099258(21)1315(01)00884838099258(21)381(01)00884838099258(21)959(01)00884838085268(21)1013(01)00884838085268(21)1412(01)00884838099258(21)232(01)00884838085268(21)460(01)00884838085268(21)1387(01)00884838099258(21)260(01)00884838099258(21)1019(01)00884838099258(21)1371(01)00884838085268(21)40(01)00884838085268(21)43(01)00884838085268(21)35(01)00884838099258(21)1049(01)00884838099258(21)1484(01)00884838099258(21)1083(01)00884838085268(21)703307(01)00884838099258(21)246(01)00884838099258(21)475
- Amount recalled
- 31 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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