The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Volcano s5/s5i Imaging System with Software Version 3.2.1/3.2.2, manufactured by Volcano Corporation.
Under very specific and remote conditions, two software display errors may occur in the 3.2.X Intravascular Ultrasound System (IVUS) software when used with Digital IVUS catheters (except PV .018 and PV 8.2) and the Rotational Revolution 45 MHz Catheter. The software display errors do not occur in the Digital IVUS Catheters if the normal (default) of 10mm Field of View (FOV) is used and in the Revolution Catheter if the system default of 8 mm FOV is used. If the software errors occur, the display will be shifted to a different FOV and will differ from the angiographic data.
If the user fails to compare the displayed data to the angiographic data as required by the Instructions for Use, the issue may be overlooked, leading to a possible error in vessel sizing with a moderate potential for restenosis or the potential placement of an additional stent. The In-Line Digital measurements, VH IVUS, ChromaFlo and Fractional Flow Reserve measurements are not affected.
The manufacturer is developing a software patch to address the errors and will contact their customers for system upgrade.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 4 September 2012