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

FDA device recall Z-1532-2013 · posted 2013-06-11 · Terminated

Recall details

Recalling firm

Embla System Llc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MNR

Quantity affected

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: Canad

Date initiated

2013-04-24

Date posted

2013-06-11

Date terminated

2017-03-07

Location

Tonawanda, NY

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