Device product
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
Z-2290-2026
Product summary
- Event
- Event 98977
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 167 units
- Official record key
device-enforcement:Z-2290-2026
Official wording
Reason: 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.
Code information: 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 pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.