| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00776-1 |
| Product Name/Description |
CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE & the Airway Gas Option N-CAiO |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Displayed Et-/Fi O2 values may be incorrect. A random deviation from the allowed tolerance limits of an O2 sensor component in the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units could cause up to 50% measurement error in Et-/Fi O2 values. An incorrect Et- /Fi O2 value could lead to a potential hypoxic situation or impaired clinical decision making. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to identify if they have any affected Airway Gas Option modules in their care. If any affected units are identified end users are requested to stop using the module and to contact technical support to arrange for correction. This action has been closed-ouit on 20/07/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |