| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01226-1 |
| Product Name/Description |
IntelliVie Information Centre (PIIC) iX (centralised patient monitor)
Affected Systems:
866023 IntelliVue Information Centre iX, A.0
866389 IntelliVue Information Centre iX, B.0
866117 PIIC Classic Upgrade
ARTG Number: 94237 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Calculated ECG leads, also referred to as reconstructed leads when viewed or printed at the Information Center iX, may misrepresent the ECG waveform morphology in some reconstructed leads. (The full set of six limb leads is commonly calculated from 2 limb leads.)
Following are the lead combinations that are affected.
· Lead I and Lead III-(aVL incorrectly reconstructed)
· Lead I and Lead aVR-(aVL Lead incorrectly reconstructed)
· Lead III and Lead aVF-(II incorrectly reconstructed)
With this combination and Hexad on, the 4 derived V leads morphology will also be misrepresented in review applications.
TRx/MX40 only – III, V or aVR, V (aVL incorrectly reconstructed) review applications only. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will be providing a software upgrade as a permanent correction. In the interm, users are informed that:
- Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG.
- The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX.
Users are also advised that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |