FDA Device recall Z-0213-2022
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722…
- FDA Device
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722… by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0213-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-24 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
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, Azurion 7 M12, Azurion 7 M20)
Reason
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.
Identifiers
| code_info | Software version 2.1.x Serial Number | Unique Device Identifier (UDI#) 140 (01)00884838099258(21)140 124 (01)008…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 ( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0213-2022%22
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