| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00848-1 |
| Product Name/Description |
Philips OmniWire Pressure Guide Wire
All OmniWire Pressure Guide Wires manufactured since February 2022 (2022-02-01)
ARTG 387961
(Philips Electronics Australia Ltd - OmniWire Pressure Guide Wire - Transducer, pressure, catheter tip) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential problem with OmniWire Pressure Guide Wire where an internal wire component could become damaged due to the wire not meeting an internal specification.
The wire component serves to transfer the signal from the sensor to the core. This condition could cause continuity problems that result in compromised electrical integrity including electrical short, no signal, loss of signal, or intermittent signal. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Continued use of the OmniWire Pressure Guide Wire should be according to the Instructions for Use (IFU). If any loss of signal were to occur during use, replace the wire with another OmniWire to complete the procedure.
If customers experience any signal problems when using the OmniWire, they are to notify their Philips representative and request for replacements.
Additionally, complaints may be submitted to IGTD.customerinquiry@Philips.com.
Philips is working with its component supplier to resolve this problem as soon as possible. Philips anticipates having new inventory available for distribution by mid of October 2024.
Supply of existing inventory will be limited. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |