Z-2878-2026Class II

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592

Name: Z-2878-2026 GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Creator: GE Medical Systems Information Technologies Inc
Published: 2026-07-10
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2026-07-10 / Open, Classified / root cause: software

FDA source

GE Medical Systems Information Technologies Inc began a recall of GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 on 2026-07-10. FDA classified it as Class II and gives the reason as "Portrait Core Services Software version V1.2.0 Security Vulnerability". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2878-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-10
Posted: 2026-08-04
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Portrait Core Services Software version V1.2.0 Security Vulnerability
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 7/10/2026 via traceable means. The notice explained the safety issue, and requested the following: "Actions to be taken by Customer/User You can continue to use Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.2.0, pending GE HealthCare correction. If you need help to identify if your Portrait Mobile Monitoring Solution has Portrait Core Services SW 1.2.0, contact GE HealthCare Service. Ensure that your facility follows all hospital networking and cybersecurity policies and procedures along with the security considerations outlined in the GE HealthCare Portrait Mobile Monitoring Solution Privacy and Security Manual p/n 5970026. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or a local Service Representative.
Quantity in commerce: 11 units
Distribution: Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
Product codes and lots: GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2878-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2878-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code MWI

K234130Class IIPortrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc. / cleared 2024-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)