| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01474-1 |
| Product Name/Description |
Volcano Imaging Systems and Core Mobile Imaging Systems
Part Numbers, 80740001, 400-0100.01, 400-0100.01-R, 400-0100.07, 400-0100.07-R, 400-0100.08, 400-0100.08R, 400-0100.02
With software version v3.5
Manufactured between 23 March 2016 to 18 October 2017
ARTG Number: 285510 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
The Microsoft Windows security settings on a small number of Impacted Systems were incorrectly configured during the manufacturing process. This misconfiguration can lead to a Windows Security Alert dialog being displayed when the system is switched from IVUS to the FFR/iFR mode. If the user responds to the dialog by selecting "Allow Access," the device's network firewall settings will be modified, opening its network ports to potential unexpected communication from the hospital network to which the device may be connected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is arranging a service technician to visit customers to inspect the system configuration. In the interim, users may follow the workaround instructions provided in the customer letter to bypass changes to the firewall permissions that may impact the system.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |