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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Rxi

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 Class 2 Recall
Precision Rxi
see related information
Date Posted August 24, 2008
Recall Status1 Open
Recall Number Z-1564-2008
Recall Event ID 46807
Premarket Notification
510(K) Number
K041605 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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. .
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 193
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GENERAL MEDICAL MERATE S.P.A.
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