| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00977-1 |
| Product Name/Description |
IntelliSpace Portal, software versions 5.0.0, 5.0.1, 5.0.2, 6.0.0, 6.0.1, 6.0.2
(Processes clinical images from different imaging modalities i.e., CT, NM, MR and enables advanced visualisation)
Models:
IntelliSpace Portal DX/HX/EX
IntelliSpace Portal IX
IntelliSpace Portal LX SPECT
ARTG Number: 188684 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The following issues could lead to misdiagnosis which may result in patient mistreatment:
1. When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed may be different from the EF originally displayed when the bookmark was first created.
2. When processing using AutoQUANT, Emory Cardiac Toolbox, Corridor4DM, or NeuroQ NM clinical applications, the patient study presented to the reviewing physician may be for a different patient than the one selected from the patient directory.
3. While using the NM Viewer application, an arrow annotation added to a display moves away from its original position if the viewer is maximised or if the image is zoomed in or out.
4. While displaying PET images within CT Viewer, the SUV results displayed are different from the one specified in system preferences. This issue affects the CT Viewer and Multi-Modality Tumour Tracking applications. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is providing users with temporary workarounds in the customer letter for the identified problems. The issues have been corrected in software versions 5.0.2.3 and 6.0.2.3. Philips Service Engineer will contact the customers for implementation of the software update on the affected systems. This action has been closed-out on 9/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |