| TGA Action ID |
RC-2025-RN-00440-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Microstream Advance, VitaLine and FilterLine Intubated CO2 Filter Lines
Multiple product numbers |
| ARTG Number |
321271 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The supplier of the Microstream Advance Intubated CO2 Filter Line, VitaLine Intubated CO2 Filter Line and FilterLine Intubated CO2 Filter Line has provided an update to the Instructions for Use (IFU) for affected product.
The IFU addendum is being issued to address customer reports of difficulty or inability to disconnect an adapter from a patient’s endotracheal tube to perform a procedure.
The addendum includes information on potential adverse events that may result from a failure to follow instructions for safe use of the airway adapter, as originally stated in the IFU.
The supplier did not identify any anomaly or non-conformance with the product. |
| Instructions for Customers/Users |
Customers can continue using the products following the updated instructions for use within the customer letter.
Customers should be aware that during set-up, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. The airway adapter can be connected to the breathing circuit/tubing in a variety of configurations. These include a direct connection to the endotracheal tube.
Philips will issue the updated IFU once available.
This action has been closed out on 29/04/2026 |
| Action Commencement Date |
5/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |