| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00602-1 |
| Product Name/Description |
Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)
ARTG Number: 131371 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Volcano Corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. In specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. This condition can occur any time, including in the middle of a patient procedure.
The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. If this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of IVUS and FFR/iFR functionality in the procedure. There have been no reports of injuries associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction. This action has been closed-out on 24/05/2017. |
| Contact Information |
02 8114 1551 - LifeHealthcare |