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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00543-1
Product Name/Description	Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors) Single-width Airway Module E-miniC Serial Numbers: 6818561 to 6898777 Extension Modules N-FC & N-FCREC Serial Numbers: 6799191 to 6905206 ARTG Number: 166230
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	15/05/2014
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	GE Healthcare has become aware of a potential safety issue due to failure of the carbon dioxide detector associated with Single-width Airway and Extension Modules. Failure of the carbon dioxide detector in Single-width Airway and Extension modules may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.
Recall Action	Recall for Product Correction
Recall Action Instructions	GE is providing calibration instructions to assist their customers to determine if their module is affected. If the carbon dioxide reading is out of range after the first successful calibration procedure end users are advised to discontinue use and contact a GE service representative. GE will arrange with customers for a correction to ensure this issue does not occur. This action has been closed-out on 02/02/2016.
Contact Information	1800 659 465 - GE Healthcare National Call Centre