CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Portrait Core Services recalled by GE Medical Systems

GE Medical Systems Information Technologies is recalling Portrait Core Services, distributed in Michigan, New York. The recall was initiated on 20 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.

Quantity recalled23 units

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-3036-2026
FDA event ID: 99536
Recalling firm: GE Medical Systems Information Technologies, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jul 2026
FDA classified: 27 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

20 Jul 2026	Recall initiated by company
27 Aug 2026	Classified by FDA	+38 days
2 Sep 2026	Published in enforcement report	+6 days

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

Reason for recall

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

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 SOFTWARE V1.1, Ref# 5700209

Where it was distributed

US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.

Michigan New York

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.

Where was it sold?

US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.

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.

Other products in this recall event

3 other products · FDA event 99536

This product is part of a recall event; the main page for the event is Portrait Core Services recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026	CLASS II	Portrait Compute And Core Services V1.2 recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026	CLASS II	Fru (Field replaceable unit), Portrait Core Services SW Reload V1.1 recalled	GE Medical Systems Information Technologies	Device Malfunction	MI, NY

More recalls from GE Medical Systems Information Technologies

All 19

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Carescape Central Station CSCS V3 MAS800 Desktop recalled	GE Medical Systems Information Technologies	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	Fru (Field replaceable unit), Portrait Core Services SW Reload V1.1 recalled	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Portrait Compute And Core Services V1.2 recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
2 Sep 2026Device	CLASS II	Portrait Core Services recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	MI, NY
12 Aug 2026Device	CLASS II	GE Healthcare Portrait Core Services SW recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	Nationwide

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