medical Class II Updated 2018-05-09

Philips Medical Systems Nederlands recalls Mutlidiagnost-Eleva with Flat Detector 708034 As a multif

Recalled Product

Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

Hazard / Issue

The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: System Serial # 201 137 223 228 219 60 272 35 111 85 121 38 120 185 168 32 30 100 235 34 148 149 67 269 191 118 170 241 210 255 8 273 33 240 131 99 193 36 138 96 222 278 257 246 23 147 162 220 47 179 221 126 195 46 144 254 189 75 56 217 83 5 167 6 154 155 156 177 183 157 245 116 62 207 81 113 134 103 115 55 200 180 175 78 93 24 106 110 123 266 3 URF.173 14 202 208 247 225 28 216 262 9 176 261 259 174 114 68 63 122 135 205 224 39 98 80 22 251 142 253 84 181 264 163 73 94 95 160 199 206 159 112 196 151 25 238 150 4 117 50 58 51 79 249 119 204 133 18 13 15 16 17 129 244 227 234 130 31 12 27 11 128 171 237 76 1 143 248 109 42 43 44 172 213 212 2 48 127 19 82 69 70 65 242 54 194 136 190 152 105 233 71 97 132 197 53 211 72 187 209 41 146 125 268 26 77 40

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