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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips North America, LLC: 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.

Agency Publication Date: March 23, 2019
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Affected Products

Product: MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular

Serial numbers 1 2 2 2 3 3 4 4 4 5 5 5 6 6 6 7 7 8 8 8 9 9 10 10 10 11 11 12 12 12 13 13 13 14 14 14 15 15 15 16 16 17 17 18 18 19 19 20 21 22 22 22 23 23 23 24 24 24 25 25 25 26 26 26 27 27 28 28 29 29 29 30 30 30 31 31 31 32 32 32 33 33 33 34 34 34 35 35 35 36 36 36 37 37 38 38 38 39 39 39 40 40 41 41 41 42 42 43 43 43 44 44 44 45 45 46 46 47 47 47 48 48 48 49 49 50 50 50 51 51 51 52 52 53 53 53 54 54 54 55 55 56 56 57 57 58 58 59 60 60 60 61 61 62 62 63 63 63 64 64 64 65 65 65 66 66 67 67 68 68 69 69 69 70 70 71 71 71 72 72 72 73 73 73 74 75 75 76 76 76 77 78 78 79 79 79 80 80 80 81 81 81 82 82 83 83 83 84 84 85 85 86 87 88 88 88 89 90 90 91 91 92 92 93 93 93 94 94 94 95 95 95 96 96 96 97 97 97 98 98 98 99 99 100 100 100 101 101 101 102 102 103 103 104 105 105 105 106 106 106 107 107 108 108 109 109 110 110 111 111 111 112 112 112 113 113 114 114 114 115 115 115 116 116 116 117 117 118 118 118 119 119 119 120 120 121 121 121 122 123 123 124 124 125 125 125 126 126 126 127 128 128 129 129 129 130 131 131 132 132 132 133 133 134 134 135 135 135 136 136 137 137 138 138 139 139 140 140 141 141 142 142 142 143 143 144 144 146 146 146 147 147 148 148 148 149 149 149 150 150 151 151 151 152 152 152 153 154 154 154 155 155 155 156 156 156 157 157 157 158 158 159 159 159 160 160 160 161 161 161 162 162 163 163 163 164 164 165 167 167 168 168 169 169 170 170 170 171 171 171 172 172 172 173 173 174 174 174 175 175 175 176 176 176 177 177 177 178 178 179 179 180 180 181 181 181 182 182 182 183 183 183 184 185 185 186 187 187 188 188 189 189 189 190 190 191 191 191 192 192 193 193 193 194 194 195 195 196 196 196 197 197 198 199 199 200 200 201 201 201 202 202 203 204 204 205 205 205 206 206 207 207 207 208 208 209 209 209 210 210 211 211 212 212 212 213 213 213 214 215 216 216 217 217 217 218 218 219 219 219 220 220 221 221 221 222 222 223 224 224 225 226 226 227 227 228 228 228 229 230 232 233 233 234 234 235 235 236 236 237 237 238 238 239 239 240 240 241 241 241 242 242 243 244 244 244 245 245 245 246 246 246 247 247 248 248 249 249 249 250 251 251 252 253 253 254 254 255 255 256 257 257 258 259 259 260 261 261 262 262 263 264 264 265 265 266 268 268 269 272 273 277 278 60268 NTS0427

Product: 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 no

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

Product: Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 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 subtrac

Serial numbers 1 2 3 4 7 9 10 11 12 13 14 15 16 17 18 19 20 22 23 24 25 26 27 28 29 30 31 32 33 34 36 38 39 41 42 44 46 47 48 49 50 51 52 53 54 56 58 60 61 62 64 65 66 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 94 95 96 97 98 101 102 103 104 104 106 107 108 109 110 111 111 112 113 115 116 117 118 118 119 120 121 123 123 124 126 127 128 129 130 131 132 133 134 135 135 136 137 138 139 140 142 143 145 146 146 147 148 149 150 151 152 153 154 156 157 158 159 161 164 165 167 173 183 195 198 199 216 217 227 251 253 259 274 281 286 297 317 323 327 333 336 340 348 353 353 358 369 378 380 390 391 393 402 421 423 426 428 438 441 466 471 473 474 481 486 498 504 514 520 530 570 574 592 598 608 664 1489 1529 3019 13124 38351 50428 76596 76948 82655 83871 83958 85163 86113 86303 86326 9341573 41355410 4163250111 708023019087 970478028909 _000364 _073 _082 _146 _302 _332 _345 _364 _371 ~~~~~~~~~~1 ~~~1 096B 1 1*015 112 11591 12 122 1232 126% 131 13310 136 14*009-Omni 141% 163 175 175 178 182 185 190 201 202 210 221 224 225 237 248 26 266 268 275 280 282 284 294 306 319 324 3243 326 3278012607 339 355 365 370 3797350-9 381 389 392 3A57204 401 4042910/000134 407 411 413554106 416 4188010/0171 419 4349690/000217 436 447 463 4665620/000374 4665620/355 4700180000326 4831320/480 60 609 66 68 708023015453 708023015995 708023018193 7080231896 70802322 7080235106 710376025944 78 8 83 84850 86549 86965 86977 87% 87164 89 90 96 97 98 99 C@20236 C@20238 C@20239 C@20241 C@20286 C@21319 C@21325 C@21338 C@21339 C@21353 C@21388 C@21389 C@21390 C@21398 C@21402 C@21406 C@21414 C@22528 C@22599 C@226 C@98168 C@99218 C@99224 GEN023210 GEN023233 M16331 M17264 M19163 M19164 M19169 M19269 M20825 M21186 M22124 S100000980/000001 S100002676/000001 S100002705/000001 S103815/1 S1048831 S3F000861A/117337 S3F000862A/117338 SN98170 URF.092 URF.130 URF.186 URF.218

Product: MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystem

4 5 7 8 9 10 11 11 12 12 13 13 14 14 14 15 16 16 17 18 18 19 20 21 21 24 24 25 25 26 26 27 28 29 29 29 30 31 31 32 32 33 34 34 35 35 36 36 37 37 38 39 40 40 41 41 42 42 43 43 44 45 46 47 47 48 48 49 49 50 51 52 53 54 55 56 57 59 61 62 67 68 71 72 73 74 75 76 77 81 83 84 84 85 86 87 88 89 90 91 92 93 98 102 103 104 105 106 107 108 109 110 112 113 114 116 118 119 120 121 122 123 123 124 125 126 127 128 129 130 132 133 135 136 137 138 139 140 142 143 145 151 153 154 157 159 160 161 162 163 164 165 166 169 170 171 172 173 174 178 180 181 182 183 184 188 189 190 193 194 196 197 198 199 201 203 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 224 225 226 227 228 229 231 232 233 235 238 239 240 241 243 244 245 246 247 248 249 251 253 254 255 256 257 258 259 260 261 261 263 264 265 266 267 268 269 270 275 276 277 278 279 280 281 282 284 286 287 288 289 290 291 292 293 294 295 296 297 298 299 305 307 308 309 310 312 314 315 316 317 318 327 329 338 339 340 341 342 343 344 345 346 347 349 350 352 353 354 355 357 358 361 362 363 364 365 366 367 368 369 372 373 374 375 376 379 380 382 383 384 388 389 391 392 393 394 396 397 398 399 399 400 401 402 403 404 405 406 407 409 411 412 413 414 415 416 417 422 424 428

Product: Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography

Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82313
Status: Resolved
Manufacturer: Philips North America, LLC
Manufactured In: United States
Units Affected: 5 products (1969; 1969; 1696; 1969; 1969)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.