FDA Device recall Z-1056-2019
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray syst…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray syst… 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-1056-2019 |
| 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
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.
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 5 6 8 11 12 12 13 13 14 15 15 16 16 17 17 18 19 20 21 22 22 23 23 24…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 24 |
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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-1056-2019%22
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