| Date Initiated by Firm | October 10, 2024 |
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| Date Posted | November 20, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0497-2025 |
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| Recall Event ID |
95604 |
| 510(K)Number | K110919 K153103 |
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| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| 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. |
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| Code Information |
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
|
| FEI Number |
3015763655
|
Recalling Firm/
Manufacturer |
Philips Medical Systems Technologies Ltd.
Matam Building 8/2
Advanced Technology Center
Haifa Israel
|
| For Additional Information Contact | Informatics Customer Support
877-328-2808 Ext. 4 |
|---|
Manufacturer 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. |
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FDA Determined
Cause 2 | 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: 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). |
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| Quantity in Commerce | 2439 systems |
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| 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
|
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LLZ
|
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