medical Class II Updated 2025-01-22

GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enab

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00195278659446, Serial Numbers: SWT24040001TA SWT24090006TA SWT24150008TA SWT24050001TA SWT24180011TA SWT24180009TA SWT31240012TA SWT24340007TA SWT24360002TA SWT24370001TA SWT24370002TA SWT24180010TA 6399074-7 6399074-8 6399074-9 6399326-1 6399326-2 SWT24060001TA
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