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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 Device 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
510(K)Number K002828 
Product Classification ENT Surgical Drill 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 FL 32216-6218
For Additional Information Contact
904-296-9600
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
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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