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U.S. Department of Health and Human Services

Class 2 Device Recall Embletta Gold

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 Class 2 Device Recall Embletta Gold see related information
Date Posted June 11, 2013
Recall Status1 Open
Recall Number Z-1532-2013
Recall Event ID 65175
510(K)Number K073682 
Product Classification Ventilatory effort recorder - Product Code MNR
Product embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).

The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient.

Item Numbers:
RMIV003465
RMIV017570
RMRE008075
UI009108
UI010814
UI013848
RMIV019053
RMIV019328
RMIV019340
RMIV019634
RMIV020254
1010005552
1010005585
1010002453
1010001588
135150668
1010003915
1010002669
RMIV019542
1010002370
UI018933
RMIV019638
RMIV019850
RMIV020166
UI012625
RMIV019235
166758580
1010007510
UI007649
RMIV020079
RMIV013196
1010002697
RMIV019658
UI016466
RMIV019659
1010002034
UI016112
UI018160
1010007423
RMRE007779
UI018158
RMIV020145
1010001332
1010002431
1010002432
1010001378
1010006090
1010007484
1010004750
1010003658
1010007351
1010002688
1010002699
UI008431
RMIV009745
RMIV019679
1010007005
1010002088
UI009365
1010003611
1010006891
UI018570
UI022540
1010002262
RMIV019517
RMIV019572
RMRE007959
UI006113
RMIV006948
UI013856
RMIV016367
RMIV019395
RMIV020112
1010005434
1010006883
RMRE007326
RMIV019237
1010006887
1010001991
1010003732
1010003984
UI002603
1010004266
1010006478
1010006800
RMIV019397
1010001928
1010001729
RMIV019166
RMIV019746
RMRE008072
UI016332
UI007631
1010002320
RMIV018044
RMRE007777
1010003067
1010005000
1010005287
RMIV019076
RMIV020194
1010000243
1010003543
1010006931
RMIV017565
RMIV019454
RMRE008087

156096
159046
RMIV020029
1010001256
1010003438
RMIV019940
RMRE008074
1010003546
UI012639
118018636
1010003507
RMIV003685
UI005216
1010003381
1010002913
1010002920
1010002845
168574112
1010006576
1010002702
1010005197
1010006074
UI012593
1010001937
1010003637
UI012586
1010002664
1010004535
1010003817
1010005998
1010006826
1010007710
1010003802
1010000965
1010001001
1010001006
1010001013
1010002659
1010002671
1010002698
1010002670
1010002646
1010002791
1010002835
1010002830
1010002793
1010003559
1010003562
1010003215
1010004145
1010004220
1010005580
1010005576
1010005464
1010005497
1010005469
1010005314
UI019628
UI007951
UI011892
RMRE004711
RMIV013784
UI015720
RMIV019570
RMRE008077
RMRE008073
1010001188
1010006437
1010004274
UI006849
UI009712
RMIV019889
UI003213
UI005546
UI011507
UI015675
RMIV019238
RMIV019254
RMIV019511
1010001255
1010003565
1010002955
UI018536
RMIV019954
RMIV019177
1010001217
UI008038
1010004985
1010002682
167617437
RMIV020243
1010005643
UI003679
1010000951
UI013298
RMIV020078
RMIV020247
1010005730
1010003680
RMIV020054
1010000199
1010007284
UI012571
UI012575
1010002675
UI014387
RMRE007776
IN000380
UI014119
UI016006
UI016355
UI017046
RMIV019982
UI005858
RMIV019919
101003924
1010002837
UI_000670
UI_001339
UI004904
RMIV007125
UI014813
UI017060
UI019513
RMIV019041
144913
RMIV019639
RMIV019778
1010002678
1010004325
1010004310
159699
1010003947
UI011502
UI020772



























































































































































































































Code Information Serial Numbers:
EBG-C1000497
C0914092-EBG
EBG-C1002589
EBG-C1002598
EBG-C1001659
EBG-C1001832
EBG-C1001835
EBG-C1001843
EBG-C1001845
EBG-C1002253
EBG-C1002473
EBG-C1002504
EBG-C1002519
EBG-C1002537
EBG-C1002539
EBG-C1001367
EBG-C1001378
EBG-C1001763
EBG-C1000265
EBG-C1002607
EBG-C1002542
EBG-C1003212
EBG-C1001834
EBG-C1001858
EBG-C1001889
EBG-C1002445
EBG-C1003052
EBG-C1002502
EBG-C1002508
EBG-C1001776
C0901065-EBG
EBG-C1003078
EBG-C1003084
EBG-C1003085
EBG-C1003161
EBG-C1003165
EBG-C1001230
EBG-C1001275
EBG-C1002688
EBG-C1002500
EBG-C1003055
EBG-C1001970
EBG-C1001972
EBG-C1001973
EBG-C1001983
EBG-C1001986
EBG-C1001518
EBG-C1000112
EBG-C1001308
EBG-C1002771
EBG-C1002863
EBG-c1001330
EBG-C1001237
C0901015-EBG
EBG-C1000118
EBG-C1001394
EBG-C1001411
EBG-C1002871
EBG-C1003067
EBG-C1002602
EBG-C1002526
EBG-C1003206
EBG-C1002321
EBG-C1000100
EBG-C1000491
EBG-C1002376
EBG-C1000032
EBG-C1001303
EBG-C1002819
EBG-C1002920
EBG-C1002530
EBG-C1002538
EBG-C1000961
EBG-C1002912
C0914083-EBG
C0917019-EBG
EBG-C1002844
EBG-C1002864
EBG-C1002924
EBG-C1002935
EBG-C1001859
EBG-C1003024
EBG-C1000061
EBG-C1002532
EBG-C1001181
EBG-C1001376
EBG-C1001546
EBG-C1001374
EBG-C1001884
EBG-C1000565
EBG-C1000101
EBG-C1000144
EBG-C1000160
EBG-C1000085
EBG-C1001228
EBG-C1001346
EBG-C1001312
EBG-C1001205
EBG-C1002974
EBG-C1003162
EBG-C1001360
EBG-C1000015
EBG-C1000097
EBG-C1000473
EBG-C1001627
C0914068-EBG
EBG-C1000987
EBG-C1000991
EBG-C1001000
EBG-C1001088
EBG-C1001097
EBG-C1001110
EBG-C1001121
EBG-C1001122
EBG-C1001123
EBG-C1001124
EBG-C1001134
EBG-C1001387
C0908065-EBG
EBG-C1002250
EBG-C1002297
EBG-C1002309
EBG-C1002311
EBG-C1002460
EBG-C1002464
EBG-C1002469
C0837085-EBG
EBG-C1000018
EBG-C1001847
EBG-C1001554
EBG-C1002371
EBG-C1002404
EBG-C1002409
EBG-C1002994
EBG-C1000002
EBG-C1000427
EBG-C1002588
EBG-C1002603
EBG-C1002842
EBG-C1002852
EBG-C1002862
EBG-C1002882
EBG-C1002886
EBG-C1002893
EBG-C1002933
EBG-C1002934
EBG-C1000574
EBG-C1003044
EBG-C1002890
EBG-C1001093
EBG-C1001094
EBG-C1001105
EBG-C1001107
EBG-C1001113
EBG-C1001125
EBG-C1001128
EBG-C1001129
EBG-C1001285
EBG-C1002263
EBG-C1002336
EBG-C1002448
EBG-C1002453
EBG-C1002462
C0826048-EBG
EBG-C1001092
EBG-C1001280
EBG-C1001286
EBG-C1001680
EBG-C1002246
EBG-C1002279
EBG-C1002310
EBG-C1002312
EBG-C1002324
EBG-C1002333
EBG-C1002335
EBG-C1002451
EBG-C1002461
EBG-C1002466
EBG-C1002470
EBG-C1002475
EBG-C1000635
EBG-C1003445
EBG-C1001606
EBG-C1001519
EBG-C1000091
EBG-C1000383
EBG-C1001325
EBG-C1001391
C0917018-EBG
EBG-C1001293
EBG-C1000034
EBG-C1002071
EBG-C1002939
EBG-C1002931
EBG-C1001297
EBG-C1003073
EBG-C1003156
EBG-C1002850
EBG-C1003193
EBG-C1003235
EBG-C1002544
C0845001-EBG
EBG-C1000459
EBG-C1000485
EBG-C1000255
C0826010-EBG
C0901029-EBG
EBG-C1000281
EBG-C1001235
EBG-C1001825
C0826121-EBG
EBG-C1002521
EBG-C1000025
EBG-C1000054
EBG-C1000080
EBG-C1000199
C0837087-EBG
EBG-C1000104
C0837006-EBG
C0901032-EBG
C0917024-EBG
C0914026-EBG
EBG-C1000156
EBG-C1000108
EBG-C1003043
EBG-C1000103
EBG-C1000125
EBG-C1002290
EBG-C1002485
EBG-C1002506
EBG-C1000498
EBG-C1001967
EBG-C1000553
EBG-C1001989
EBG-C1001996
EBG-C1001998
EBG-C1001999
EBG-C1002000
EBG-C1002002
EBG-C1002003
EBG-C1002315
EBG-C1003468
EBG-C1000984
EBG-C1001024
EBG-C1001114
EBG-C1003418
EBG-C1002481
EBG-C1000935
EBG-C1002486
EBG-C1001133
EBG-C1001258
EBG-C1000062
EBG-C1001350
EBG-C1002513
EBG-C1001404
EBG-C1001816
C0837060-EBG
EBG-C1001476
EBG-C1002005
EBG-C1002007
EBG-C1002017
EBG-C1001108
EBG-C1000968
EBG-C1003231
EBG-C1000969
EBG-C1001897
EBG-C1002559
EBG-C1002558
EBG-C1002564
EBG-C1002570
EBG-C1002732
EBG-C1002943
EBG-C1002976
EBG-C1002993
EBG-C1003030
EBG-C1002568
EBG-C1003019
EBG-C1002396
EBG-C1002432
EBG-C1002557
EBG-C1002565
EBG-C1004025
C0837050-EBG
EBG-C1001020
EBG-C10
Recalling Firm/
Manufacturer
Embla System Llc
250 Cooper Ave
Tonawanda NY 14150-6633
Manufacturer Reason
for Recall
Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Embla Systems, LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter on April 24, 2013, to their customers via courier. The letter described the product, problem and actions to be taken. The customers were instructed to return all recalled units for recalibration and to contact Technical Support at 1-888-662-7632, option #1, at your earliest convenience; Reference the EBG Field Corrective Action in order to obtain your return number. Embla will provide overnight shipping both ways and a three business day turn around for affected units. If you have transferred any of these products to another location, please forward a copy of this urgent notification to that location and notify Manager, Quality and Regulatory Affairs, at 613-254-8877 ext 1105 or via email at EBGFieldCorrectionProgram@natus.com.
Quantity in Commerce 519 units were calibrated at the service center
Distribution Worldwide distribution: US (nationwide) including states of: CO, AK, WA, CA, WI, MI, MA OH, DE, FL CA, CT, TX, IL, GA, PA, AZ, DC, VA, MD, UT, IN, MO, NY, NC, OR, NV, NJ, NH, DE, and country of: Canada.
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 = MNR and Original Applicant = EMBLA SYSTEMS, INC.
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