GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile…

Recall date

December 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0918-2025

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of OH, TX and the countries of Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, UAE, UK.

Why it was recalled

There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB