Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling Azurion Interventional Fluoroscopic X-ray Systems due to two operational issues. The first issue involves intermittent failure of communication between the control unit and the stand movement mechanism during system start-up. The second issue involves improper execution of warm restart after emergency stop activation, which prevents movement functionality from becoming available.
The recall affects 10 units total, with one unit distributed in the United States and nine units distributed internationally across Washington state, France, Germany, Japan, Poland, and the United Kingdom. The recalled systems include various Azurion models (Azurion 3, Azurion 5, and Azurion 7 in different configurations) with specific serial numbers and model numbers listed in the recall documentation. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Reason for recall: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available Distribution: Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom. Quantity: 10 units (1 US and 9 OUS) Lot/code info: US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.