notyard
09-04-2008, 08:11 AM
FDA class II recall:
PRODUCT
a) GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System.
It is a remote analog R&F system consisting of a tilting table with integrated spot
film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The
system can be configured to meet a wide variety of exams for various clinical
applications with ether 23 cm image intensifier with 512x512 Image Chain
or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image
Chain, Recall # Z-1563-2008;
b) 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,
Recall # Z-1564-2008;
c) GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System.
It is a remote analog R&F system consisting of a tilting table with integrated spot
film device, and 50KW or 65 kW pulsing generator. The system is configured with
a 23 cm image intensifier and a 512x512 Image Chain, Recall # Z-1565-2008
CODE
a) Units: 101 103 117 121 128 132 133 135 136 152 156 160 162 164 173 178 182 184
190 194 196 201 202 209 221 228 232 235 238 240 246 250 251 252 254 259 260
261 263 264 267 268 273 275 276 281 283 289 295 297 300 302 310 322 330 331
333 342 343 347 348 351 353 354 365 367;
b) Units: 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;
c) Units: 10805 10805 10805 10804 10804 10804
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letters dated December 18, 2007 and March 7, 2008.
Manufacturer: General Medical Merate, Seriate, Italy. Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
265 systems
DISTRIBUTION
Nationwide
PRODUCT
a) GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System.
It is a remote analog R&F system consisting of a tilting table with integrated spot
film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The
system can be configured to meet a wide variety of exams for various clinical
applications with ether 23 cm image intensifier with 512x512 Image Chain
or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image
Chain, Recall # Z-1563-2008;
b) 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,
Recall # Z-1564-2008;
c) GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System.
It is a remote analog R&F system consisting of a tilting table with integrated spot
film device, and 50KW or 65 kW pulsing generator. The system is configured with
a 23 cm image intensifier and a 512x512 Image Chain, Recall # Z-1565-2008
CODE
a) Units: 101 103 117 121 128 132 133 135 136 152 156 160 162 164 173 178 182 184
190 194 196 201 202 209 221 228 232 235 238 240 246 250 251 252 254 259 260
261 263 264 267 268 273 275 276 281 283 289 295 297 300 302 310 322 330 331
333 342 343 347 348 351 353 354 365 367;
b) Units: 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;
c) Units: 10805 10805 10805 10804 10804 10804
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letters dated December 18, 2007 and March 7, 2008.
Manufacturer: General Medical Merate, Seriate, Italy. Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
265 systems
DISTRIBUTION
Nationwide