| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00542-1 |
| Product Name/Description |
Masimo uSpO2 and HPLP Oximetry Cables
ARTG Number: 202606 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
A small number of Oximetry Cables have been identified with crossed-internal wires.
The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally, in the same Oximetry Cable, when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Philips is providing instructions for hospitals to verify the performance of the oximetry cables. If the cables are not working as expected they are to be returned to Philips for replacement or refund. This action has been closed-out on 06/09/2016. |
| Contact Information |
1300 776 488 - Philips Customer Care Centre |