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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 02686
EBG-C1000971
EBG-C1000650
EBG-C1001080
EBG-C1001782
EBG-C1002605
EBG-C1001537
EBG-C1001761
EBG-C1001785
EBG-C1002033
EBG-C1002039
EBG-C1002040
EBG-C1002177
EBG-C1002627
EBG-C1001306
EBG-C1002004
EBG-C1002652
EBG-C1002035
C0917072-EBG
EBG-C1000110
EBG-C1002164
EBG-C1002591
C0917044-EBG
EBG-C1000059
EBG-C1000114
EBG-C1000963
EBG-C1001764
EBG-C1001797
EBG-C1002566
EBG-C1003236
EBG-C1001679
EBG-C1001758
EBG-C1001768
EBG-C1002023
EBG-C1002609
EBG-C1001422
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EBG-C1001424
EBG-C1001545
EBG-C1001770
EBG-C1002009
EBG-C1002016
EBG-C1002615
EBG-C1002025
EBG-C1001362
EBG-C1001695
EBG-C1001765
EBG-C1001779
EBG-C1002022
EBG-C1002739
EBG-C1002011
EBG-C1000079
EBG-C1000041
EBG-C1000043
EBG-C1000063
EBG-C1000355
EBG-C1001675
EBG-C1001749
EBG-C1002855
EBG-C1001403
EBG-C1001968
EBG-C1001987
EBG-C1001988
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EBG-C1001290
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EBG-C1001549
EBG-C1001783
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EBG-C1003223
EBG-C1001322
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EBG-C1002610
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EBG-C1001015
C0914041-EBG
EBG-C1001245
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EBG-C1001539
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EBG-C1002899
EBG-C1000016
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EBG-C1001498
EBG-C1001524
EBG-C1001529
EBG-C1001611
EBG-C1001798
EBG-C1001864
EBG-C1001867
EBG-C1001878
EBG-C1001883
EBG-C1000115
EBG-C1000989
EBG-C1001379
EBG-C1001979
EBG-C1002618
EBG-C1002716
EBG-C1001753
EBG-C1001548
EBG-C1001648
EB2-C1000137
EBG-C1003075
C0837037-EBG
EBG-C1003065
EBG-C1000578
C0914065-EBG
EBG-C1001264
EBG-C1001406
EBG-C1002913
EBG-C1001799
EBG-C1002680
EBG-C1000587
EBG-C1001224
EBG-C1002338
EBG-C1000992
EBG-C1002109
EBG-C1001806
EBG-C1002106
EBG-C1002225
EBG-C1002226
EBG-C1002227
EBG-C1002232
EBG-C1002233
EBG-C1002243
EBG-C1001821
EBG-C1000181
EBG-C1002234
EBG-C1000142
EBG-C1000279
EBG-C1002275
EBG-C1002586
EBG-C1002590
EBG-C1002750
EBG-C1001516
EBG-C1002006
EBG-C1002916
EBG-C1002027
EBG-C1002029
EBG-C1002031
EBG-C1001615
EBG-C1002188
EBG-C1002369
EBG-C1002413
EBG-C1002435
EBG-C1002436
EBG-C1002489
EBG-C1002534
EBG-C1002540
EBG-C1001366
EBG-C1000277
EBG-C1002364
EBG-C1002548
EBG-C1002571
EBG-C1002563
EBG-C1002787
EBG-C1002554
EBG-C1002555
EBG-C1002556
EBG-C1002753
EBG-C1002952
EBG-C1002964
EBG-C1002965
EBG-C1002970
EBG-C1002982
EBG-C1003018
EBG-C1003021
EBG-C1003027
EBG-C1003040
EBG-C1001383
EBG-C1001023
EBG-C1001091
EBG-C1001762
EBG-C1003486
EBG-C1003470
EBG-C1000457
EBG-C1000476
EBG-C1000424
EBG-C1000437
EBG-C1000561
EBG-C1001504
EBG-C1002497
EBG-C1003026
EBG-C1003661
EBG-C1001860
C0914014-EBG
EBG-C1001790
EBG-C1000449
EBG-C1002217
EBG-C1002797
EBG-C1002399
EBG-C1002363
EBG-C1002410
EBG-C1002411
EBG-C1002419
EBG-C1002420
EBG-C1002950
C0914045-EBG
EBG-C1000052
EBG-C1002267
EBG-C1002021
EBG-C1003582
EBG-C1003620
C0914086-EBG
EBG-C1001368
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
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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