Z-0471-2022 Class II Terminated
FDA device recall Z-0471-2022 was initiated by Philips North America Llc on November 12, 2021 and is designated Class II. 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… The recall status is terminated (terminated February 5, 2024). Affected quantity: 10 units (1 US and 9 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- November 12, 2021
- Termination Date
- February 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units (1 US and 9 OUS)
Product Description
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
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 Pattern
Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.
Code Information
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