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FDA (Device enforcement)Recalled 2019-02-28closedclass ii

Philips North America, LLC: Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controll

Is my product affected?

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 examina

  • UPC 708023019087
  • UPC 970478028909
  • UPC 4700180000326
  • UPC 708023015453
  • UPC 708023015995
  • UPC 708023018193
  • UPC 710376025944

Check against the official notice below — it lists the full affected range.

What happened

Philips North America is recalling approximately 1,696 Omnidiagnost Classic X-ray systems with product codes 70859, 708023, 708024, and 708025. These multi-functional X-ray systems may be missing a locking plate, which can cause the stand or table to tilt unexpectedly in a way that the user cannot stop. The affected systems were distributed nationwide in the United States as well as internationally.

The recall involves a specific set of serial numbers. The source document does not specify what remedy or action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: US Nationwide domestic distribution, and worldwide international distribution. Quantity: 1696 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

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

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