Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, A
Check against the official notice below — it lists the full affected range.
Philips North America is recalling Azurion Interventional Fluoroscopic X-Ray Systems with software version 2.1.x across multiple model numbers (722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, and 72222). The recall affects 428 devices distributed in the United States and 581 devices distributed internationally. The hazard occurs when a user simultaneously presses or releases both the APC (accept) button and the Float Tabletop (panning) button, which can cause the system's geometry to stop responding to movement requests, resulting in table lock-up and unavailable X-ray imaging.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
Reason for recall: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable. Distribution: Domestic distribution nationwide. International distribution worldwide. Quantity: 428 (US); 581 (OUS) Lot/code info: Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)00884838099241(21)124 75 (01)00884838099258(21)75 824 (01)00884838085251(21)824 182 (01)00884838099258(21)182 703416 (01)00884838085268(21)703416 626 (01)00884838085251(21)626 697 (01)00884838085251(21)697 3 (01)00884838099203(21)3 703368 (01)00884838085268(21)703368 139 (01)00884838099258(21)139 159 (01)00884838099258(21)159 36 (01)00884838099241(21)36 266 (01)00884838099258(21)266 512 (01)00884838099258(21)512 703413 (01)00884838085268(21)703413 1410 (01)00884838085268(21)1410 703329 (01)00884838085268(21)703329 250 (01)00884838099258(21)250 226 (01)00884838099258(21)226 105 (01)00884838099272(21)105 360 (01)00884838099258(21)360 370 (01)00884838099258(21)370 1379 (01)00884838085268(21)1379 452 (01)00884838099258(21)452 141 (01)00884838085251(21)141 279 (01)00884838085251(21)279 644 (01)00884838085251(21)644 455 (01)00884838085268(21)455 48 (01)00884838099234(21)48 584 (01)00884838099258(21)584 239 (01)00884838099272(21)239 34 (01)00884838099258(21)34 131 (01)00884838099241(21)131 88 (01)00884838099258(21)88 890 (01)00884838085251(21)890 15 (01)00884838099210(21)15 19 (01)00884838099210(21)19 919 (01)00884838085268(21)919 33 (01)00884838099258(21)33 792 (01)00884838085268(21)792 469 (01)00884838085367(21)469 53 (01)00884838099258(21)53 469 (01)00884838085367(21)469 363 (01)00884838099258(21)363 409 (01)00884838099258(21)409 260 (01)00884838085282(21)260 261 (01)00884
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.