medical Class II Updated 2018-05-09

Philips Medical Systems Nederlands recalls Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detec

Recalled Product

Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 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 # 40 239 123 58 88 172 129 81 136 159 244 238 82 65 249 70 142 188 128 178 117 45 203 79 229 199 126 158 71 60 187 47 197 87 152 105 76 26 124 139 35 15 66 241 150 86 230 22 206 207 222 146 29 151 111 190 59 228 155 4 233 92 30 221 163 201 91 69 44 205 48 18 34 171 110 175 121 174 43 160 185 23 202 209 95 144 50 141 156 708032/14 72 93 98 193 262 189 118 218 153 33 104 53 216 177 116 38 64 196 49 181 37 180 164 240 135 183 17 125 170 54 NL73 113 90 24 6 27 42 73 246 133 84 214 83 192 149 169 62 61 191 195 100 227 236 97 99 101 102 46 219 103 226 173 89 140 2 36 20 80 32 161 5 51 94 12 176 212 179 25 96 39 154 63 182 157 85 200 234 19 132 21 165 13 120 41 10 56 55 3 7 8 106 114 108 213 14 115 107 31 112

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