20

Nov

2024

FDA Recall: Software Issue May Cause Incorrect Ischemic Map and Calculations Resulting in Misdiagnosis

0

Company: Philips Medical Systems Technologies Ltd.
Date of Enforcement Report: 11/20/2024

Class: II

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.

Recall Number:

Z-0497-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Philips Medical Systems Technologies Ltd.

VOLUME OF PRODUCT 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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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