Philips Azurion Interventional Fluoroscopic X-ray recall
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery…
Why was Philips Azurion Interventional Fluoroscopic X-ray recalled?
(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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery…
- Recalling firm
- Philips North America Llc
- Quantity
- 10 units (1 US and 9 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)