510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0497-2025Class II

Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended...

Philips Medical Systems Technologies Ltd. / initiated 2024-10-10 / Open, Classified / root cause: software
FDA source (opens on fda.gov)

Philips Medical Systems Technologies Ltd. began a recall of Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-0497-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips Medical Systems Technologies Ltd.
Product
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
Product code
LLZ System, Image Processing, Radiological
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.
Root cause tag
software
FDA root cause
Software design
Action
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: [email protected]. 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).
Quantity in commerce
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 City State) Hong Kong Hungary Indonesia Ireland Israel Italy Japan Jersey Jordan Lebanon Malaysia Mexico Netherlands New Zealand Norway Oman Panama Philippines Poland Portugal Romania Saudi Arabia Serbia Slovenia Spain Sweden Switzerland Taiwan Thailand United Kingdom
Product codes and lots
UDI-DI: (01)00884838100350(11)200221(10)12.2.5; (01)00884838100350(11)200812(10)12.2.6.0; (01)00884838100350(11)201207(10)12.2.6.100; (01)00884838100350(11)210303(10)12.2.6.200; (01)00884838100350(11)210518(10)12.2.6.201; (01)00884838100350(11)210729(10)12.2.6.300; (01)00884838100350(11)210502(10)12.2.8.0; (01)00884838100350(11)220112(10)12.2.8.100; (01)00884838100350(11)221213(10)12.2.8.200; (01)00884838100350(11)230301(10)12.2.8.210; (01)00884838100350(11)230320(10)12.2.8.300; (01)00884838100350(11)230608(10)12.2.8.310; (01)00884838100350(11)230718(10)12.2.8.400; (01)00884838100350(11)230810(10)12.2.8.401; (01)00884838100350(11)230824(10)12.2.8.317; (01)00884838100350(11)231019(10)12.2.8.412; (01)00884838100350(11)231108(10)12.2.8.403; (01)00884838100350(11)231129(10)12.2.8.413; (01)00884838100350(11)231214(10)12.2.8.414; (01)00884838100350(11)231204(10)12.2.8.420; (01)00884838100350(11)240101(10)12.2.8.415; (01)00884838100350(11)240116(10)12.2.8.421; (01)00884838100350(11)240204(10)12.2.8.422; (01)00884838100350(11)240226(10)12.2.8.424; (01)00884838100350(11)240311(10)12.2.8.426; (01)00884838100350(11)240407(10)12.2.8.440; (01)00884838100350(11)240425(10)12.2.8.450; (01)00884838100350(11)240613(10)12.2.8.451; (01)00884838100350(11)240715(10)12.2.8.452; (01)00884838100350(11)240715(10)12.2.8.454; (01)00884838100350(11)230926(10)12.2.8.410

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0497-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0497-2025Class IIOngoingVoluntary: Firm initiated