FDA Class II · Medical device · Recall Z-2290-2026 · Recalled June 10, 2026
Philips Azurion 7M12 recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Compare identifiers Agency action Open official record ↗ Agency report date: June 10, 2026.
Source checks: September 7, 2026 at 6:00 AM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
FDA: stored recall dates April 29, 2026 to August 19, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
1. Compare your item 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.
Product named Philips Azurion 7M12 Company / brand PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Lot / serial / date 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, (01)00884838085251(21)786, (01)00884838099241(21)365, (01)00884838099241(21)390, (01)00884838099241(21)186, (01)00884838099241(21)187, (01)00884838099241(21)631, (01)00884838099241(21)87, (01)00884838099241(21)373, (01)00884838099241(21)514, (01)00884838099241(21)69, (01)00884838099241(21)256, (01)00884838099241(21)679, (01)00884838099241(21)29, (01)00884838099241(21)67, (01)00884838099241(21)503, (01)00884838099241(21)432, (01)00884838099241(21)131, (01)00884838099241(21)704, (01)00884838099241(21)301, (01)00884838099241(21)456, (01)00884838085251(21)803, (01)00884838099241(21)659, (01)00884838099241(21)242, (01)00884838099241(21)746, (01)00884838099241(21)171, (01)00884838099241(21)457, (01)00884838099241(21)455, (01)00884838099241(21)221, (01)00884838099241(21)454, (01)00884838099241(21)318, (01)00884838099241(21)229, (01)00884838099241(21)230, (01)00884838099241(21)262, (01)00884838085251(21)890, (01)00884838085251(21)626, (01)00884838085251(21)697, (01)00884838099241(21)308, (01)00884838099241(21)124, (01)00884838099241(21)198, (01)00884838099241(21)433, (01)00884838085251(21)684, (01)00884838099241(21)566, (01)00884838099241(21)126, (01)00884838085251(21)829, (01)00884838099241(21)880, (01)00884838085251(21)143, (01)00884838099241(21)665, (01)00884838099241(21)188, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838099241(21)367, (01)00884838099241(21)52, (01)00884838099241(21)371, (01)00884838099241(21)127, (01)00884838099241(21)105, (01)00884838099241(21)572, (01)00884838099241(21)104, (01)00884838099241(21)334, (01)00884838099241(21)627, (01)00884838099241(21)458, (01)00884838099241(21)487, (01)00884838099241(21)463, (01)00884838099241(21)470, (01)00884838085251(21)902, (01)00884838099241(21)96, (01)00884838099241(21)277, (01)00884838099241(21)211, (01)00884838085251(21)317, (01)00884838085251(21)709, (01)00884838099241(21)97, (01)00884838099241(21)161, (01)00884838099241(21)386, (01)00884838099241(21)208, (01)00884838099241(21)361, (01)00884838099241(21)258, (01)00884838099241(21)597, (01)00884838085251(21)725, (01)00884838085251(21)728, (01)00884838099241(21)180, (01)00884838085251(21)441, (01)00884838099241(21)668, (01)00884838099241(21)377, (01)00884838099241(21)882, (01)00884838085251(21)906, (01)00884838099241(21)565, (01)00884838099241(21)223, (01)00884838099241(21)196, (01)00884838099241(21)130, (01)00884838099241(21)453, (01)00884838099241(21)452, (01)00884838099241(21)269, (01)00884838085251(21)788, (01)00884838099241(21)567, (01)00884838099241(21)449, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)644, (01)00884838099241(21)435, (01)00884838099241(21)441, (01)00884838085251(21)844, (01)00884838085251(21)876, (01)00884838085251(21)748, (01)00884838099241(21)669, (01)00884838099241(21)351, (01)00884838099241(21)508, (01)00884838099241(21)750, (01)00884838099241(21)164. Distribution US Nationwide distribution. Agency product description and boundaries 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 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.
2. Agency hazard and consumer action FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Philips Azurion 7M12
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-2290-2026 Brand PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Classification Class II Units affected 167 units Recall status Ongoing Affected products Companies & origin Recalling firm location Best, Netherlands Firm address Veenpluis 6, N/A Identifying details (verbatim from the notice) Product codes / lots 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, (01)00884838085251(21)786, (01)00884838099241(21)365, (01)00884838099241(21)390, (01)00884838099241(21)186, (01)00884838099241(21)187, (01)00884838099241(21)631, (01)00884838099241(21)87, (01)00884838099241(21)373, (01)00884838099241(21)514, (01)00884838099241(21)69, (01)00884838099241(21)256, (01)00884838099241(21)679, (01)00884838099241(21)29, (01)00884838099241(21)67, (01)00884838099241(21)503, (01)00884838099241(21)432, (01)00884838099241(21)131, (01)00884838099241(21)704, (01)00884838099241(21)301, (01)00884838099241(21)456, (01)00884838085251(21)803, (01)00884838099241(21)659, (01)00884838099241(21)242, (01)00884838099241(21)746, (01)00884838099241(21)171, (01)00884838099241(21)457, (01)00884838099241(21)455, (01)00884838099241(21)221, (01)00884838099241(21)454, (01)00884838099241(21)318, (01)00884838099241(21)229, (01)00884838099241(21)230, (01)00884838099241(21)262, (01)00884838085251(21)890, (01)00884838085251(21)626, (01)00884838085251(21)697, (01)00884838099241(21)308, (01)00884838099241(21)124, (01)00884838099241(21)198, (01)00884838099241(21)433, (01)00884838085251(21)684, (01)00884838099241(21)566, (01)00884838099241(21)126, (01)00884838085251(21)829, (01)00884838099241(21)880, (01)00884838085251(21)143, (01)00884838099241(21)665, (01)00884838099241(21)188, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838099241(21)367, (01)00884838099241(21)52, (01)00884838099241(21)371, (01)00884838099241(21)127, (01)00884838099241(21)105, (01)00884838099241(21)572, (01)00884838099241(21)104, (01)00884838099241(21)334, (01)00884838099241(21)627, (01)00884838099241(21)458, (01)00884838099241(21)487, (01)00884838099241(21)463, (01)00884838099241(21)470, (01)00884838085251(21)902, (01)00884838099241(21)96, (01)00884838099241(21)277, (01)00884838099241(21)211, (01)00884838085251(21)317, (01)00884838085251(21)709, (01)00884838099241(21)97, (01)00884838099241(21)161, (01)00884838099241(21)386, (01)00884838099241(21)208, (01)00884838099241(21)361, (01)00884838099241(21)258, (01)00884838099241(21)597, (01)00884838085251(21)725, (01)00884838085251(21)728, (01)00884838099241(21)180, (01)00884838085251(21)441, (01)00884838099241(21)668, (01)00884838099241(21)377, (01)00884838099241(21)882, (01)00884838085251(21)906, (01)00884838099241(21)565, (01)00884838099241(21)223, (01)00884838099241(21)196, (01)00884838099241(21)130, (01)00884838099241(21)453, (01)00884838099241(21)452, (01)00884838099241(21)269, (01)00884838085251(21)788, (01)00884838099241(21)567, (01)00884838099241(21)449, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)644, (01)00884838099241(21)435, (01)00884838099241(21)441, (01)00884838085251(21)844, (01)00884838085251(21)876, (01)00884838085251(21)748, (01)00884838099241(21)669, (01)00884838099241(21)351, (01)00884838099241(21)508, (01)00884838099241(21)750, (01)00884838099241(21)164. Distribution US Nationwide distribution. Firm notified the public via Letter FDA event ID 98977 Recall initiated December 7, 2023 FDA classified June 1, 2026 FDA report date June 10, 2026
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.
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