Reported Jun 19, 2013 · Terminated

embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a…

Embla System LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Embla System Llc · 250 Cooper Ave · Tonawanda, NY · 14150-6633

Is this the product you have?

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
224 of 224 codes
- 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
UI_000670 UI_001339
- UI004904
- RMIV007125
- UI014813
- UI017060
- UI019513
- RMIV019041
- 144913
- RMIV019639
- RMIV019778
- 1010002678
- 1010004325
- 1010004310
- 159699
- 1010003947
- UI011502
- UI020772

Lot codes and dates: Serial Numbers
516 of 516 codes
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
C0914086-EBG EBG-C1001368 Item Numbers
224 of 224 codes
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
UI_000670 UI_001339
UI004904
RMIV007125
UI014813
UI017060
UI019513
RMIV019041
144913
RMIV019639
RMIV019778
1010002678
1010004325
1010004310
159699
1010003947
UI011502
UI020772
Amount recalled: 519 units were calibrated at the service center

Where it was sold

Nationwide
CO
AK
WA
CA
WI
MI
MA
OH
DE
FL
CT
TX
IL
GA
PA
AZ
DC
VA
MD
UT
IN
MO
NY
NC
OR
NV
NJ
NH

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Where it was distributed

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