Ventilatory Effort Recorder

Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder)

The outer jacket is receding away from the black sensor prematurely.

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

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.

Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31.

When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen.

The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Pr

The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient .

Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics,

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysvil

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Error in the device firmware results in the inaccurate detection of device position.