| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00715-1 |
| Product Name/Description |
Volcano IVUS Ultrasound Imaging System
Volcano s5 and CORE Series
Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Volcano Corp. has discovered a very specific workflow scenario where the Aortic pressure (Pa) offset used in the FFR/iFR modalities will be lost or reset to 0 mmHg due to a software error. This issue can lead to an inaccurately calculated FFR or iFR value. Should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition.
If the Pa was not zeroed through the Volcano system as part of the workflow, this software issue has no impact on the FFR / iFR values or on the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medical Vision Australia is advising their customers that if zeroing Pa is warranted, as described in the FFR Option Operator's Manual, performance of this product cannot be assured until the software update is provided. A Medical Vision Australia Representative will contact affected hospitals to schedule a correction to the software in the next few weeks. This action has been closed-out on 24/08/2016. |
| Contact Information |
1300 661 559 - Medical Vision Australia |