medical Class II Updated 2018-05-09

Philips Medical Systems Nederlands recalls MultiDim Eleva 708032 As a multifunctional universal im

Recalled Product

MultiDim Eleva 708032 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 # 32 177 259 239 264 258 52 67 111 257 94 142 121 191 143 260 265 74 207 101 182 174 124 263 4 172 254 151 246 64 183 76 152 188 261 242 102 34 147 241 134 178 245 176 175 38 162 107 220 65 194 69 247 13 215 78 112 29 139 98 79 158 61 33 106 35 50 16 80 205 161 11 204 37 12 189 9 232 15 228 155 47 171 213 209 218 96 90 212 217 181 163 140 114 115 108 71 141 14 36 48 224 25 105 57 216 138 24 28 211 160 192 43 44 157 154 41 219 8 68 129 75 221 7 10 63 146 45 26 125 193 210 1 60 3 132 81 22 23 208 5 131 135 88 226 6 156 49 91 92 93 201 250 251 72 95 148 39 31 2 30 51 100 255 252 256 109 196 164 170 227 173 83 159 53 137 54 116 118 119 167 168 169 97

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