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Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 114...

FDA Device Recall #Z-0497-2025 — Class II — October 10, 2024

Recall Summary

Recall Number Z-0497-2025
Classification Class II — Moderate risk
Date Initiated October 10, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems Technologies Ltd.
Location Haifa, N/A
Product Type Devices
Quantity 2439 systems

Product Description

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 Pattern

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

Lot / 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

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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