Reported Jun 10, 2026 · Ongoing
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 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 7B20/15
- Model Numbers722068, 722226 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
156 of 156 codes
UDI (01)00884838085367(21)547(01)00884838099272(21)120(01)00884838099272(21)122(01)00884838099272(21)123(01)00884838099272(21)124(01)00884838099272(21)125(01)00884838099272(21)126(01)00884838099272(21)127(01)00884838099272(21)153(01)00884838099272(21)67(01)00884838099272(21)209(01)00884838099272(21)271(01)00884838099272(21)675(01)00884838099272(21)112(01)00884838085367(21)467(01)00884838085367(21)335(01)00884838099272(21)113(01)00884838099272(21)121(01)00884838099272(21)139(01)00884838099272(21)158(01)00884838085367(21)455(01)00884838085367(21)494(01)00884838099272(21)239(01)00884838099272(21)105(01)00884838099272(21)678(01)00884838099272(21)362(01)00884838099272(21)114(01)00884838085367(21)564(01)00884838099272(21)403(01)00884838085367(21)418(01)00884838085367(21)440(01)00884838099272(21)108(01)00884838099272(21)545(01)00884838099272(21)197(01)00884838099272(21)380(01)00884838099272(21)281(01)00884838099272(21)495(01)00884838099272(21)319(01)00884838099272(21)339(01)00884838099272(21)182(01)00884838099272(21)183(01)00884838085367(21)64(01)00884838099272(21)325(01)00884838099272(21)100(01)00884838099272(21)272(01)00884838099272(21)680(01)00884838085367(21)42(01)00884838099272(21)255(01)00884838099272(21)341(01)00884838099272(21)687(01)00884838099272(21)350(01)00884838099272(21)280(01)00884838085367(21)323(01)00884838099272(21)270(01)00884838099272(21)254(01)00884838099272(21)107(01)00884838099272(21)144(01)00884838085367(21)109(01)00884838099272(21)294(01)00884838099272(21)559
- Amount recalled
- 156 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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