| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00163-1 |
| Product Name/Description |
Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5
Multiple Serial Numbers
ARTG Number: 230620 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
A problem was uncovered which causes images processed with Pharmacokinetic (PK) results and/or DynaCAD calculated Apparent Diffusion Coefficient (ADC) maps have incorrect colour overlay results as well as in the case of the ADC images, incorrect values reported. The defect exists on any DynaCAD client system running software versions 3.4 or 3.5. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising users to discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected.
Philips will provide a v4.0 software update for the affected software versions as a permanent correction.
This action has been closed out on 06/02/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |