CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

Portrait Core Services, a set recalled by GE Medical Systems

GE Medical Systems is recalling Portrait Core Services, a set, distributed nationwide in the US. The recall was initiated on 6 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled7 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0918-2025
FDA event ID: 96027
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 6 Dec 2024
FDA classified: 15 Jan 2025
Reported: 22 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

6 Dec 2024	Recall initiated by company
15 Jan 2025	Classified by FDA	+40 days
22 Jan 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was 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.

Nationwide Texas

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
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14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide