| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00620-1 |
| Product Name/Description |
Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC
All units serviced with Field Replaceable Unit catalogue number M1013204 between February 2012 and May 2014.
ARTG Number: 166230 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2014 |
| Responsible Entity |
|
| 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.
This action has been undertaken further to the previous recall action (RC-2014-RN-00543-1) since GE has identified that all units serviced with Field Replaceable Unit catalogue number M1013204 between February 2012 and May 2014 are affected by this issue. |
| 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. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |