Vue PACS Diagnostic Viewer with Vue PACS client 12 — Class II medical device recall Z-0497-2025
Ongoing recall by Philips Medical Systems Technologies Ltd., reported 2024-11-27, distributed nationwide. A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when
| Recall number | Z-0497-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Technologies Ltd., Haifa, N/A, Israel |
| Recall initiated | 2024-10-10 |
| Classified | 2024-11-20 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CH, CL, CN, CO, DE, DK, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IT, JO, JP, LB, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, RO, RS, SA, SE, SI, TH, TW |
| Quantity | 2,439 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838100350 |
| Model numbers | 1149418 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0497-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.