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Embla System Recalls
1 recall on record · June 19, 2013 to June 19, 2013 · Medical Devices
June 19, 2013
Medical Devices
FDA
Embla System Llc recalls embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is
Hazard: 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.
Embla System Recalls | RecallWatchUSA