Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips ...
FDA Device Recall #Z-1054-2019 — Class II — February 28, 2019
Recall Summary
| Recall Number | Z-1054-2019 |
| 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 | 1696 |
Product Description
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 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 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
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| 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.