# FDA recall Z-0497-2025

> **Philips Medical Systems Technologies Ltd.** · Class II · device recall initiated 2024-10-10.

## 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.

## 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

## Key facts

- **Recall number:** Z-0497-2025
- **Recalling firm:** Philips Medical Systems Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-10
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Haifa, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2025

## Citation

> AI Analytics. FDA recall Z-0497-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0497-2025. Source: US FDA. Licensed CC0.

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