Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to p

FDA device recall Z-0497-2025 · posted 2024-11-20 · Open, Classified

Recall details

Recalling firm

Philips Medical Systems Technologies Ltd.

Reason for recall

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

Action taken

Philips issued URGENT Medical Device Correction letter(# 2024-EI-RI-001) via Fed'x on 10/10/24 to US consignees. Philips Markets organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: To prevent the issue from occurring, Philips recommends that users not use the Perfusion Application Export function (as shown in Figure 4). When used without export functionality, the Perfusion Application performs as expected. " You may continue to use your system(s) in accordance with the intended use and by following the recommendation above. " If a study is reloaded in the Perfusion Application after an export action is performed, and the Perfusion/Diffusion Warning message is observed (shown in Figure 1), the ischemic map and table value calculations should not be used for diagnostic purposes. " Circulate this notice to all users of this device so that they are aware of the potential issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: EICnR@philips.com. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a time to install a software solution on your system(s) to resolve the issue (reference FCO78000003). Philips plans to begin installing the solution on affected systems in October 2024. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact Informatics Customer Support (1-877-328-2808, Option 4).

Root cause

Software design

Status

Open, Classified

Product code

LLZ

Quantity affected

2439 systems

Distribution

US Nationwide and Worldwide Distribution Foreign: Country Argentina Australia Austria Belgium Brazil Chile China Colombia Denmark Finland France Germany Gibraltar Greece Guernsey Holy See (Vatican Cit

Date initiated

2024-10-10

Date posted

2024-11-20

Location

Haifa, Israel

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