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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Power Console System

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 Class 2 Recall
Integrated Power Console System
see related information
Date Posted November 13, 2009
Recall Status1 Terminated on January 20, 2010
Recall Number Z-0259-2010
Recall Event ID 53603
Premarket Notification
510(K) Number
K002828 
Product Classification Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece - Product Code ERL
Product Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA. Distributed by: Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137 USA. No difference between two referenced Consoles (REF numbers differ for internal sales tracking purposes).
Code Information Serial Numbers International Distribution: 51033 51106 51107 51120 51121 51122 51123 51124 51128 51135 51157 51167 51169 51174 51175 51176 51177 51178 51182 51183 51184 51185 51217 51220 51291 51308 51334 51344 51349 51350 51356 51378 51388 51439 51508 51635 71002 71037 71041 71045 71082 71170 71198 71206 71247 71270 71280 71298 71303 71324 71335 71336 71337 71339 71340 71341 71345 71347 71349 71350 71356 71357 71358 71360 71361 71368 71375 71381 71387 71388 71431 71432 71433 71434 71435 71437 71438 71439 71440 71441 71454 71455 71456 71457 71468 71472 71494 71495 71507 71508 71509 71517 71519 71520 71521 71532 71533 71534 71545 Serial Numbers Domestic Distribution: 51003 51009 51010 51011 51012 51013 51014 51015 51016 51018 51024 51027 51030 51031 51035 51040 51041 51042 51046 51051 51052 51057 51058 51062 51064 51066 51067 51068 51069 51070 51071 51072 51073 51074 51075 51076 51079 51080 51081 51082 51084 51085 51086 51087 51089 51104 51108 51115 51125 51126 51129 51131 51151 51152 51153 51154 51164 51203 51207 51208 51209 51210 51211 51212 51215 51216 51218 51219 51221 51222 51223 51224 51225 51226 51227 51228 51229 51230 51231 51232 51233 51234 51274 51276 51278 51279 51280 51281 51282 51284 51285 51286 51287 51288 51290 51292 51293 51294 51296 51297 51298 51299 51300 51309 51315 51317 51319 51321 51323 51324 51326 51333 51336 51341 51342 51348 51354 51358 51375 51376 51379 51380 51383 51384 51385 51386 51387 51399 51400 51402 51403 51404 51407 51418 51422 51425 51428 51429 51430 51431 51432 51433 51434 51435 51438 51440 51441 51443 51445 51446 51452 51453 51454 51465 51466 51467 51468 51469 51470 51471 51472 51473 51474 51475 51476 51477 51478 51481 51482 51486 51487 51488 51489 51491 51492 51493 51494 51495 51496 51497 51498 51499 51504 51507 51513 51515 51516 51517 51518 51518 51519 51520 51521 51522 51523 51524 51529 51530 51531 51534 51535 51536 51537 51544 51545 51546 51550 51551 51567 51570 51573 51576 51577 51578 51580 51581 51583 51586 51587 51589 51591 51592 51593 51594 51596 51597 51600 51601 51604 51605 51606 51608 51609 51610 51610 51611 51612 51614 51615 51618 51619 51622 51623 51625 51628 51629 51630 51631 51632 51633 51636 51637 51640 51641 51642 51645 51646 71033 71048 71049 71100 71108 71133 71136 71138 71143 71148 71150 71156 71161 71169 71222 71229 71239 71265 71268 71269 71272 71274 71277 71281 71283 71285 71286 71295 71306 71307 71312 71315 71318 71334 71342 71343 71344 71348 71352 71353 71359 71364 71369 71374 71376 71377 71382 71383 71384 71385 71386 71390 71392 71394 71395 71399 71400 71401 71402 71404 71406 71407 71408 71409 71410 71411 71412 71416 71417 71418 71419 71420 71421 71423 71424 71426 71427 71428 71429 71430 71444 71445 71446 71448 71449 71460 71461 71464 71465 71466 71467 71469 71470 71473 71474 71475 71476 71477 71478 71479 71480 71481 71482 71483 71485 71486 71488 71490 71492 71493 71499 71500 71503 71504 71506 71510 71522 71523 71524 71525 71527 71528 71529 71530 71542 71543 71544 71546 71547 71549 71550 71551 71553 71554 71555 71558 71559, and 71573.
Recalling Firm/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville, Florida 32216-6218
Manufacturer Reason
for Recall
An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console.
FDA Determined
Cause 2
DESIGN: Software Design
Action A Product Correction Notification was issued to each consignee on June 15, 2009. Medtronic sales representatives will visit each facility to advise consignees of the issue and to install a software upgrade that will correct the handpiece recognition issue on the console(s).
Quantity in Commerce 493
Distribution Worldwide Distribution
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 = ERL and Original Applicant = XOMED, INC.
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