Reported Jan 22, 2025 · Ongoing
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI00195278659446
- Serial Numbers
SWT24040001TASWT24090006TASWT24150008TASWT24050001TASWT24180011TASWT24180009TASWT31240012TASWT24340007TASWT24360002TASWT24370001TASWT24370002TASWT24180010TA6399074-76399074-86399074-96399326-16399326-2SWT24060001TA
- Amount recalled
- 7 systems
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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