URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagno...
FDA Device Recall #Z-1056-2019 — Class II — February 28, 2019
Recall Summary
| Recall Number | Z-1056-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 28, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 1969 |
Product Description
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
Reason for Recall
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Distribution Pattern
US Nationwide domestic distribution, and worldwide international distribution.
Lot / Code Information
Serial numbers 1 2 3 4 5 6 8 11 12 12 13 13 14 15 15 16 16 17 17 18 19 20 21 22 22 23 23 24 24 25 26 27 28 29 29 30 30 32 32 33 33 34 34 35 35 36 36 37 37 38 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 54 55 57 58 59 60 61 62 63 64 65 67 68 69 70 71 72 73 76 77 78 79 80 82 83 84 85 86 88 89 90 91 94 96 97 98 100 101 102 103 105 106 107 108 109 110 111 112 113 114 116 117 118 119 120 121 122 123 124 125 126 128 129 130 131 133 134 135 136 138 139 140 141 143 144 145 147 148 151 152 153 154 155 156 157 158 159 160 163 164 165 166 167 168 169 170 171 173 174 175 176 177 178 179 181 182 184 185 192 193 194 195 196 197 198 199 201 202 203 204 205 206 210 211 212 215 216 217 218 219 220 221 222 224 226 227 228 230 231 232 234 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 255 256 257 258 259 262 263 265 266 267 268 269 270 271 272 273 274 275 277 278 279 280 281 283 284 287 289 290 291 292 293 294 295 296 298 299 301 302 303 304 305 308 311 313 314 316 317 319 320 321 322 323 324 325 326 327 328 329 330 332 333 334 335 336 337 340 341 342 346 347 348 351 352 353 354 355 359 360 361 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 383 384 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 404 405 406 407 408 409 410 411 412 413 414 417 418 421 422 423 426 427 429 430 432 433 434 435 436 439 440 441 442 444 445 447 449 450 451 452 453 454 456 458 459 460 461 462 463 464 470 471 472 473 474 475 477 478 479 480 482 483 484 485 486 487 488 489 490 491 492 493 494 496 497 500 501 503 504 505 506 508 511 513 514 515 516 517 518 519 522 525 530 532 533 534 535 537 538 539 540 544 545 546 547 550 551 552 554 555 556 557 558 559 560 562 563 564 565 566 567 573 574 575 576 577 578 579 580 581 582 583 586 587 589 590 591 592 593 595 596 597 598 599 600 602 603 604 607 608 610 611 612 613 614 615 616 619 620 621 622 623 624 625 626 4060046 000033/064322 314 503X
Other Recalls from Philips North America, LLC
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|---|---|---|---|
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes... | Feb 7, 2022 |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Us... | Mar 23, 2021 |
| Z-0852-2021 | Class II | Emission Computed Tomography System Image Proce... | Nov 19, 2020 |
| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
| Z-0285-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.