Events

Rappel de Device Recall Precision Rxi

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    46807
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1564-2008
  • Date de mise en oeuvre de l'événement
    2007-12-18
  • Date de publication de l'événement
    2008-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68303
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Image-intensified x-ray, fluoroscopic system - Product Code JAA
  • Cause
    Ge healthcare precision rxi tilt joystick became stuck in the trendelenburg direction causing the patient to slide off the table. also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-ge remote r&f; system. .
  • Action
    Two letters "GE Product Safety Notification" dated 12/18/07 and 3/7/08, addressed to Hospital Administrators, Manager of Radiology and Radiologists, were sent to each consignee. Each letter addressed a separate safety issue. Letters described the affected product, safety instructions, corrective action and contact information. The joystick can become stuck causing unintentional motion of the tube. Field Modification Instructions (FMI 10802/10803) have been issued to the field to install additional warning labels on the patient table, install a protector for the console joystick and inspect and correct the clearance between the console joystick and its mounting location. If your facility has a Precision RXi or Precision e system manufactured before March 2007, a GE Healthcare Field Engineer will schedule a field visit to install the added joystick protection. This upgrade will be performed at no charge. If you have any questions/concerns regarding this issue, please contact your local GE Healthcare sales or service representative.

Device

Device Recall Precision Rxi
  • Modèle / numéro de série
    100 102 104 105 106 107 108 109 110 111 112 113 114 115 116 118 119 120 122 123 124 125 126 127 129 130 131 134 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 153 154 155 157 158 159 161 163 165 166 167 168 169 170 171 172 174 175 176 177 179 180 181 183 185 186 187 188 189 191 192 193 195 197 198 199 200 203 204 205 207 208 210 211 212 213 214 215 216 217 218 219 220 222 223 224 225 226 227 229 230 231 233 234 236 237 239 241 242 243 244 245 247 248 249 253 255 256 257 258 262 265 266 269 270 271 272 274 277 278 279 280 282 284 285 286 287 288 290 291 292 293 296 301 303 305 306 307 308 309 311 312 313 314 315 316 317 318 319 320 321 323 324 325 326 327 328 329 332 335 336 337 338 339 340 341 344 345 346 349 350 352 355 356 357 358 359 360 361 368
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    (USA) AK CO IL LA MA MI MS NC NJ NY PA SC TN UT VA WA WI (OUSA) BR CA MX AU C3 KR PH TW AE AT BE BF BG CM CY CZ DE ES FI FR GB GE GR GY HR HU IT LB LV MT NA NG PL PT RO RU SA SD SE SI SK SY TN TR UA YU ZA
  • Description du dispositif
    GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F; System. It is a remote R&F; system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32 cm or 40 cm image intensifier.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Adresse du fabricant
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA