| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01473-1 |
| Product Name/Description |
Volcano s5i, CORE, CORE Mobile Systems with software version V3.5
Part Numbers: 80740001, 400-0100.07, and 400-0100.02
Manufactured between 23 March 2016 to 18 October 2017
ARTG Number: 131371 |
| 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Life Healthcare is arranging a service technician to visit customers to validate affected systems. 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 17/10/2018. |
| Contact Information |
02 8114 1553 - LifeHealthcare |