Reported Jun 10, 2026 · Ongoing
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the…
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 5M20
- Model Numbers722228 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)00884838099234(21)67(01)00884838099234(21)49(01)00884838099234(21)10(01)00884838099234(21)36(01)00884838099234(21)64(01)00884838099234(21)110(01)00884838099234(21)328(01)00884838099234(21)149(01)00884838099234(21)213(01)00884838099234(21)45(01)00884838099234(21)159(01)00884838099234(21)18(01)00884838099234(21)231(01)00884838099234(21)61(01)00884838099234(21)204(01)00884838099234(21)273(01)00884838099234(21)76(01)00884838099234(21)150(01)00884838099234(21)132(01)00884838099234(21)189(01)00884838099234(21)17(01)00884838099234(21)47(01)00884838099234(21)38(01)00884838099234(21)87(01)00884838099234(21)128(01)00884838099234(21)32(01)00884838099234(21)23(01)00884838099234(21)25(01)00884838099234(21)62(01)00884838099234(21)181(01)00884838099234(21)177(01)00884838099234(21)48(01)00884838099234(21)153(01)00884838099234(21)79(01)00884838099234(21)80(01)00884838099234(21)157(01)00884838099234(21)24(01)00884838099234(21)187(01)00884838099234(21)26(01)00884838099234(21)29(01)00884838099234(21)122(01)00884838099234(21)127(01)00884838099234(21)6(01)00884838099234(21)123(01)00884838099234(21)124(01)00884838099234(21)92(01)00884838099234(21)215(01)00884838099234(21)91(01)00884838099234(21)205(01)00884838099234(21)20(01)00884838099234(21)37a
- 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.
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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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