| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01518-1 |
| Product Name/Description |
Philips Intellivue Patient Monitor X3
ARTG Numbers: 213953 and 118076 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has discovered that the NBP measurement of X3 intermittently displays only mean values instead of the diastolic and systolic blood pressure values. Furthermore, occasionally the Monitor shows the ‘Check Touch Input” message, indicating that the touchscreen controls may not function. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will distribute a software update for the affected devices and replace the display assembly. Philips has provided a workaround until the corrections are implemented.
Users should consider using an alternative monitor in situations where the touchscreen controls are needed when using the X3 in standalone mode.
This action has been closed out on 09/07/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |