MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I unive...
FDA Device Recall #Z-1052-2019 — Class II — February 28, 2019
Recall Summary
| Recall Number | Z-1052-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 28, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 1969 |
Product Description
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.
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.
Distribution Pattern
US Nationwide domestic distribution, and worldwide international distribution.
Lot / Code Information
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
Other Recalls from Philips North America, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0926-2022 | Class II | The IFU for the Autoclavable Temperature Probes... | Feb 7, 2022 |
| Z-1326-2021 | Class II | Philips SureSigns VM4, VM6 and VM8 - Product Us... | Mar 23, 2021 |
| Z-0852-2021 | Class II | Emission Computed Tomography System Image Proce... | Nov 19, 2020 |
| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
| Z-0285-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.