CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
MultiDiagnost-Eleva, Product codes recalled by Philips North America
Philips North America is recalling MultiDiagnost-Eleva, Product codes 708032, 708036, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1052-2019
- FDA event ID
- 82313
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2019
- FDA classified
- 23 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 28 Feb 2019 | Recall initiated by company | |
| 23 Mar 2019 | Classified by FDA | +23 days |
| 3 Apr 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide domestic distribution, and worldwide international distribution.
Questions about this recall
Is MultiDiagnost-Eleva, Product codes 708032, 708036 recalled?
Yes. Philips North America recalled MultiDiagnost-Eleva, Product codes 708032, 708036 on 28 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1052-2019.
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide domestic distribution, and worldwide international distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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