Notice names this product. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V’s Philips Azurion 7B12/12 is named in FDA Class II recall Z-2288-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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.. Units affected: 51 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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 with the Roadmap Pro Software key
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 tou…
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Affected product: Philips Azurion 7B12/12
Official ID Z-2288-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.