FDA Device recall Z-1054-2019
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal… by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1054-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-28 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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 subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
Reason
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.
Identifiers
| 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…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 8 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1054-2019%22
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