| TGA Action ID |
RC-2026-RN-00645-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ForeSight Oximeter Cable
Catalogue Number: HEMFSM10
Date of Manufacture: 1 June 2021 to 30 June 2026
Multiple Serial Numbers |
| ARTG Number |
461366 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Edwards Lifesciences has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device.
There is potential that the labels on the green cables may have been switched, with the channel 1 cable labelled as channel 2, and the channel 2 cable labelled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables.
Should this potential problem occur during use, the values displayed on the monitor will be switched and will represent the opposite region being monitored. Therefore, there is a potential for incorrect diagnosis, leading to potential delay of appropriate treatment.
To date, three complaints have been received about this problem worldwide, none of which resulted in adverse events. |
| Instructions for Customers/Users |
Customers are to check devices in clinical use and in inventory:
1. Verify for the presence of the flag, sensor, and channel labels on the device.
2. Verify that the flag and sensor labels correspond to the correct channel label (A1 on left / B2 on right) on the housing.
3. If either of the labels are missing, or the flag label and/or the sensor label do not match the channel label on the housing, contact Technical Support for further assistance. |
| Action Commencement Date |
26/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 222 601 - Edwards Lifesciences Customer Service |