Recall of Device Recall Fresenius 2008T Hemodialysis Machine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Holdings, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57851
  • Event Risk Class
    Class 2
  • Event Number
    Z-1526-2011
  • Event Initiated Date
    2011-01-19
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-07-08
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Cursor on the dialysis screen may disappear and not respond to user input.
  • Action
    Fresenius Medical Care contacted customers by mailing a Customer Notification letter "Urgent correction FMNCA Model 2008T Hemodialysis Machine" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.

Device

  • Model / Serial
    Units distributed between Sept 1, 2010 and January 5, 2011. Serial Numbers: 0T0S100031 0T0S100035 0T0S100036 0T0S100037 0T0S100039 0T0S100040 0T0S100041 0T0S100042 0T0S100046 0T0S100048 0T0S100050 0T0S100052 0T0S100058 0T0S100059 0T0S100060 0T0S100061 0T0S100062 0T0S100063 0T0S100064 0T0S100065 0T0S100067 0T0S100068 0T0S100070 0T0S100071 0T0S100072 0T0S100080 0T0S100084 0T0S100085 0T0S100086 0T0S100087 0T0S100088 0T0S100089 0T0S100090 0T0S100093 0T0S100094 0T0S100095 0T0S100096 0T0S100097 0T0S100098 0T0S100099 0T0S100100 0T0S100101 0T0S100102 0T0S100103 0T0S100105 0T0S100107 0T0S100109 0T0S100110 0T0S100111 0T0S100113 0T0S100114 0T0S100115 0T0S100116 0T0S100117 0T0S100118 0T0S100119 0T0S100121 0T0S100122 0T0S100123 0T0S100124 0T0S100125 0T0S100126 0T0S100127 0T0S100129 0T0S100130 0T0S100131 0T0S100132 0T0S100133 0T0S100135 0T0S100136 0T0S100137 0T0S100138 0T0S100139 0T0S100140 0T0S100141 0T0S100142 0T0S100143 0T0S100144 0T0S100145 0T0S100146 0T0S100147 0T0S100148 0T0S100149 0T0S100150 0T0S100151 0T0S100152 0T0S100153 0T0S100154 0T0S100155 0T0S100156 0T0S100157 0T0S100158 0T0S100159 0T0S100160 0T0S100161 0T0S100162 0T0S100163 0T0S100164 0T0S100165 0T0S100166 0T0S100167 0T0S100168 0T0S100170 0T0S100171 0T0S100172 0T0S100173 0T0S100174 0T0S100175 0T0S100176 0T0S100177 0T0S100179 0T0S100180 0T0S100181 0T0S100182 0T0S100183 0T0S100184 0T0S100185 0T0S100186 0T0S100187 0T0S100188 0T0S100189 0T0S100190 0T0S100191 0T0S100192 0T0S100193 0T0S100194 0T0S100195 0T0S100196 0T0S100197 0T0S100198 0T0S100199 0T0S100200 0T0S100202 0T0S100203 0T0S100204 0T0S100205 0T0S100206 0T0S100207 0T0S100208 0T0S100210 0T0S100211 0T0S100212 0T0S100213 0T0S100214 0T0S100215 0T0S100216 0T0S100217 0T0S100218 0T0S100220 0T0S100221 0T0S100222 0T0S100223 0T0S100224 0T0S100225 0T0S100226 0T0S100227 0T0S100228 0T0S100229 0T0S100230 0T0S100231 0T0S100232 0T0S100233 0T0S100234 0T0S100235 0T0S100236 0T0S100237 0T0S100238 0T0S100239 0T0S100240 0T0S100241 0T0S100242 0T0S100243 0T0S100244 0T0S100245 0T0S100246 0T0S100247 0T0S100248 0T0S100249 0T0S100250 0T0S100251 0T0S100252 0T0S100253 0T0S100254 0T0S100255 0T0S100256 0T0S100257 0T0S100258 0T0S100259 0T0S100260 0T0S100261 0T0S100262 0T0S100263 0T0S100264 0T0S100265 0T0S100266 0T0S100267 0T0S100268 0T0S100270 0T0S100271 0T0S100272 0T0S100274 0T0S100275 0T0S100276 0T0S100277 0T0S100280 0T0S100281 0T0S100282 0T0S100284 0T0S100285 0T0S100286 0T0S100288 0T0S100289 0T0S100291 0T0S100293 0T0S100294 0T0S100295 0T0S100296 0T0S100297 0T0S100298 0T0S100299 0T0S100300 0T0S100301 0T0S100302 0T0S100303 0T0S100304 0T0S100305 0T0S100306 0T0S100307 0T0S100308 0T0S100309 0T0S100310 0T0S100311 0T0S100312 0T0S100313 0T0S100314 0T0S100315 0T0S100316 0T0S100317 0T0S100318 0T0S100319 0T0S100320 0T0S100321 0T0S100322 0T0S100323 0T0S100324 0T0S100325 0T0S100326 0T0S100327 0T0S100328 0T0S100329 0T0S100330 0T0S100331 0T0S100332 0T0S100333 0T0S100334 0T0S100335 0T0S100336 0T0S100337 0T0S100338 0T0S100339 0T0S100340 0T0S100341 0T0S100342 0T0S100343 0T0S100344 0T0S100345 0T0S100346 0T0S100347 0T0S100348 0T0S100349 0T0S100350 0T0S100351 0T0S100352 0T0S100353 0T0S100354 0T0S100355 0T0S100356 0T0S100357 0T0S100358 0T0S100359 0T0S100360 0T0S100361 0T0S100362 0T0S100363 0T0S100364 0T0S100365 0T0S100366 0T0S100367 0T0S100368 0T0S100369 0T0S100370 0T0S100371 0T0S100372 0T0S100373 0T0S100374 0T0S100375 0T0S100376 0T0S100377 0T0S100378 0T0S100379 0T0S100380 0T0S100381 0T0S100382 0T0S100383 0T0S100384 0T0S100385 0T0S100386 0T0S100387 0T0S100388 0T0S100389 0T0S100390 0T0S100391 0T0S100392 0T0S100393 0T0S100394 0T0S100395 0T0S100396 0T0S100397 0T0S100398 0T0S100399 0T0S100400 0T0S100401 0T0S100402 0T0S100403 0T0S100404 0T0S100405 0T0S100406 0T0S100407 0T0S100408 0T0S100409 0T0S100410 0T0S100411 0T0S100412 0T0S100413 0T0S100414 0T0S100415 0T0S100416 0T0S100417 0T0S100418 0T0S100419 0T0S100420 0T0S100421 0T0S100422 0T0S100423 0T0S100424 0T0S100425 0T0S100426 0T0S100427 0T0S100428 0T0S100429 0T0S100430 0T0S100431 0T0S100432 0T0S100433 0T0S100434 0T0S100435 0T0S100436 0T0S100437 0T0S100438 0T0S100439 0T0S100440 0T0S100441 0T0S100442 0T0S100443 0T0S100444 0T0S100445 0T0S100446 0T0S100447 0T0S100448 0T0S100449 0T0S100450 0T0S100451 0T0S100452 0T0S100453 0T0S100454 0T0S100455 0T0S100456 0T0S100457 0T0S100458 0T0S100459 0T0S100460 0T0S100461 0T0S100462 0T0S100463 0T0S100464 0T0S100465 0T0S100466 0T0S100467 0T0S100468 0T0S100469 0T0S100470 0T0S100471 0T0S100472 0T0S100473 0T0S100474 0T0S100475 0T0S100477 0T0S100478 0T0S100479 0T0S100480 0T0S100481 0T0S100483 0T0S100484 0T0S100485 0T0S100486 0T0S100487 0T0S100488 0T0S100489 0T0S100490 0T0S100491 0T0S100492 0T0S100493 0T0S100494 0T0S100495 0T0S100496 0T0S100497 0T0S100498 0T0S100499 0T0S100500 0T0S100501 0T0S100502 0T0S100503 0T0S100504 0T0S100505 0T0S100506 0T0S100507 0T0S100508 0T0S100509 0T0S100510 0T0S100511 0T0S100512 0T0S100513 0T0S100514 0T0S100515 0T0S100516 0T0S100517 0T0S100518 0T0S100519 0T0S100520 0T0S100521 0T0S100522 0T0S100523 0T0S100524 0T0S100525 0T0S100526 0T0S100527 0T0S100528 0T0S100529 0T0S100530 0T0S100531 0T0S100532 0T0S100533 0T0S100534 0T0S1005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  • Distribution
    Worldwide Distribution - USA and Canada
  • Product Description
    Fresenius 2008T Hemodialysis Machine || Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS || Part Number 190713, 2008T Hemodialysis System with CDX || Part Number 190766, 2008T Hemodialysis System with biBag || The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
  • Source
    USFDA