—#171334

Product

MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K023441
Affected lot / code info: 4 5 7 8 9 10 11 11 12 12 13 13 14 14 14 15 16 16 17 18 18 19 20 21 21 24 24 25 25 26 26 27 28 29 29 29 30 31 31 32 32 33 34 34 35 35 36 36 37 37 38 39 40 40 41 41 42 42 43 43 44 45 46 47 47 48 48 49 49 50 51 52 53 54 55 56 57 59 61 62 67 68 71 72 73 74 75 76 77 81 83 84 84 85 86 87 88 89 90 91 92 93 98 102 103 104 105 106 107 108 109 110 112 113 114 116 118 119 120 121 122 123 123 124 125 126 127 128 129 130 132 133 135 136 137 138 139 140 142 143 145 151 153 154 157 159 160 161 162 163 164 165 166 169 170 171 172 173 174 178 180 181 182 183 184 188 189 190 193 194 196 197 198 199 201 203 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 224 225 226 227 228 229 231 232 233 235 238 239 240 241 243 244 245 246 247 248 249 251 253 254 255 256 257 258 259 260 261 261 263 264 265 266 267 268 269 270 275 276 277 278 279 280 281 282 284 286 287 288 289 290 291 292 293 294 295 296 297 298 299 305 307 308 309 310 312 314 315 316 317 318 327 329 338 339 340 341 342 343 344 345 346 347 349 350 352 353 354 355 357 358 361 362 363 364 365 366 367 368 369 372 373 374 375 376 379 380 382 383 384 388 389 391 392 393 394 396 397 398 399 399 400 401 402 403 404 405 406 407 409 411 412 413 414 415 416 417 422 424 428

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US Nationwide domestic distribution, and worldwide international distribution.

Timeline

Recall initiated: 2019-02-28
Terminated: 2020-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.