Recall Z-1532-2013 ยท MNR Ventilatory Effort Recorder
Embla System Llc
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 lif
| Date | Jun 11, 2013 (initiated Apr 24, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 product |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073682 | EMBLETTA GOLD Embla Systems, Inc., Aug 8, 2008 |