Reported Jun 10, 2026 · Ongoing
Philips Azurion 7M12, Model Numbers: 722078, 722223 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 7M12
- Model Numbers722078, 722223 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
167 of 167 codes
UDI (01)00884838099241(21)85(01)00884838099241(21)312(01)00884838099241(21)332(01)00884838099241(21)533(01)00884838099241(21)479(01)00884838099241(21)189(01)00884838099241(21)47(01)00884838085251(21)840(01)00884838099241(21)352(01)00884838099241(21)681(01)00884838099241(21)391(01)00884838099241(21)328(01)00884838085251(21)870(01)00884838099241(21)388(01)00884838099241(21)581(01)00884838099241(21)570(01)00884838099241(21)77(01)00884838099241(21)448(01)00884838099241(21)571(01)00884838099241(21)495(01)00884838085251(21)679(01)00884838099241(21)439(01)00884838099241(21)628(01)00884838099241(21)36(01)00884838099241(21)580(01)00884838099241(21)799(01)00884838099241(21)577(01)00884838085251(21)513(01)00884838085251(21)833(01)00884838085251(21)566(01)00884838099241(21)323(01)00884838099241(21)252(01)00884838099241(21)626(01)00884838099241(21)261(01)00884838099241(21)125(01)00884838099241(21)207(01)00884838099241(21)329(01)00884838099241(21)560(01)00884838099241(21)561(01)00884838099241(21)205(01)00884838099241(21)379(01)00884838099241(21)440(01)00884838099241(21)204(01)00884838099241(21)192(01)00884838099241(21)197(01)00884838085251(21)921(01)00884838099241(21)177(01)00884838085251(21)700(01)00884838099241(21)37(01)00884838099241(21)340(01)00884838099241(21)357(01)00884838099241(21)282(01)00884838099241(21)214(01)00884838085251(21)1007(01)00884838099241(21)44(01)00884838085251(21)862(01)00884838099241(21)210(01)00884838099241(21)336(01)00884838099241(21)206(01)00884838099241(21)343
- Amount recalled
- 167 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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