| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01082-1 |
| Product Name/Description |
Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)
Affected Products: Philips MX 16-slice CT Systems with software version v2.0.0.21479
ARTG Number: 158775 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
In 2D and Filming function, when image is zoomed and saved as derived DICOM format, the measurement on new created image is incorrect. This issue only occurs on MX16 systems with software version v2.0.0.21479, including MX16 EVO2 systems and MX 16 systems upgraded to MX16 EVO2 using the MX16 iDose4 Upgrade Kit.
Image with incorrect measurement value may be used to guide clinical procedures where measurement is critical. This may lead to misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
An initial workaround is provided for users in the Customer Letter. Philips will release Field Change Order (FCO) 72800646 to upgrade the software free of change. A Philips Field Engineer will contact users to schedule this correction. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |