PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Az

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 1,993 US; 2,662 ROW Lot/code info: 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 1382 18 19 212 213 216 222 227 228 229 239 241 247 250 251 255 262 263 266 267 268 273 274 275 281 29 290 296 297 298 299 30 314 318 32 320 325 326 327 33 334 335 34 343 344 345 35 350 351 353 354 355 356 357 358 359 360 361 366 374 375 387 393 394 40 401 402 403 407 408 41 412 413 414 415 417 420 422 423 424 427 428 429 43 436 437 438 439 445 447 448 45 453 455 459 46 460 465 466 468 469 47 470 471 472 474 479 48 483 488 497 50 51 52 520 525 526 528 53 534 535 536 54 540 543 55 56 564 57 572 573

UPC codes

00884838059290, 00884838064775, 00884838085350, 00884838059207, 00884838085367, 00884838085251, 00884838099241, 00884838059191, 00884838059221, 00884838085268, 00884838086777

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.