🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: February 28, 2019 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1056-2019

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