Recall Ledger

GE Healthcare Portrait Core Services SW V 1.2.0 recall (GE Medical Systems Information Technologies Inc)

Medical deviceClass IIOngoing

Summary: GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system. Reason: A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

What is being recalled

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

Why

A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. (states named: Michigan)

How to tell if yours is affected

GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2878-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 10, 2026
ReportedAugust 12, 2026
CompanyGE Medical Systems Information Technologies Inc
Company locationWaukesha, WI, United States
Initiated byVoluntary: Firm initiated
Quantity11 units

More recalls from GE Medical Systems Information Technologies Inc · all medical device recalls · recalls from July 2026

Official FDA record