FDA Device recall Z-1145-2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system by Philips Medical Systems Nederland B V, citing framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching betw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-02 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
Reason
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Identifiers
| code_info | Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 104 131 133 141 148 26 3…Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 104 131 133 141 148 26 36 41 42 46 57 69 70 71 75 81 92 98 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, or 00884838085367 Serial Numbers 101 103 104 107 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 232 243 247 261 262 277 288 295 322 330 356 361 470 64 73 75 76 78 82 84 85 89 95 ; Azurion 7 M12 722078 - UDI-DI 00884838085251 Serial Numbers 121 125 136 141 163 165 166 187 215 224 232 239 240 249 251 256 257 258 269 271 278 279 289 290 291 292 293 294 296 298 302 305 308 309 31 317 327 359 360 364 376 379 383 384 396 399 402 412 415 425 436 437 438 441 445 456 478 479 480 481 483 491 493 497 500 523 524 535 537 538 539 550 571 , 722223 - UDI-DI 00884838099241 Serial Number 206 ; Azurion 7 M20 722079 - UDI-DI 00884838059191, 00884838059221, 00884838059290, 00884838085268, 00884838086777 Serial Numbers 1018 1042 1063 1211 1267 1274 1380 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2024%22
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