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U.S. Department of Health and Human Services

Class 2 Device Recall Embletta Gold

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 Class 2 Recall
Embletta Gold
see related information
Date Posted June 11, 2013
Recall Status1 Open
Recall Number Z-1532-2013
Recall Event ID 65175
Premarket Notification
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-C1002686 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 EBG-C1001418 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 EBG-C1002613 EBG-C1001290 EBG-C1001343 EBG-C1001549 EBG-C1001783 EBG-C1002026 EBG-C1002710 EBG-C1003238 EBG-C1003223 EBG-C1001322 EBG-C1001375 EBG-C1001393 EBG-C1001407 EBG-C1001413 EBG-C1001421 EBG-C1001507 EBG-C1001511 EBG-C1001513 EBG-C1001517 EBG-C1001525 EBG-C1001526 EBG-C1001530 EBG-C1001693 EBG-C1001750 EBG-C1001772 EBG-C1001774 EBG-C1001777 EBG-C1001778 EBG-C1001781 EBG-C1001784 EBG-C1002024 EBG-C1002032 EBG-C1001278 EBG-C1001323 EBG-C1002019 EBG-C1002569 EBG-C1002610 EBG-C1002616 EBG-C1002678 EBG-C1002708 EBG-C1001015 C0914041-EBG EBG-C1001245 EBG-C1002735 EBG-C1001539 EBG-C1002881 EBG-C1002899 EBG-C1000016 EBG-C1001470 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 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
Recalling Firm/
Manufacturer
Embla System Llc
250 Cooper Ave
Tonawanda, New York 14150-6633
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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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