| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00364-1 |
| Product Name/Description |
IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)
Affected IntelliSpace Portal software versions: v5.0.0, v5.0.1, v5.0.2 and v6.0.0
ARTG Number: 188684 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal with the software versions mentioned above. In addition, resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on IntelliSpace Portal unless the data is acquired with VXGP collimators. The occurrence of either problem may result in image quality degradation that could result in misdiagnosis under certain conditions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing work around instructions to ensure the continued safe use of the AutoSPECT Pro until a software update can be provided to correct the issue. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |