Who should I contact about this recall?

Contact GE Medical Systems Information Technologies Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Recall Record: Class II Recall: GE Healthcare Portrait Core Services SW V 1.2.0,… by GE Medical Systems Information Technologies Inc

At a glance: FDA classified a recall by GE Medical Systems Information Technologies Inc as Class II, reported 20260812. The affected product is GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system (recall number Z-2878-2026). Reason for recall: 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).. Status: Ongoing. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall.

Key facts

Recalling firm	GE Medical Systems Information Technologies Inc
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Classification	Class II
Recall number	Z-2878-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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 consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from GE Medical Systems Information Technologies Inc. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from GE Medical Systems Information Technologies Inc should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to GE Medical Systems Information Technologies Inc directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

GE Medical Systems Information Technologies Inc’s FDA history

Argus HQ has recorded 9 total FDA actions tied to GE Medical Systems Information Technologies Inc: 0 warning letters, 9 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 recalled?: FDA's recall record states the reason as: 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).
Who should I contact about this recall?: Contact GE Medical Systems Information Technologies Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
Has GE Medical Systems Information Technologies Inc had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 9 total FDA actions tied to GE Medical Systems Information Technologies Inc, including 9 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2878-2026.

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Full FDA history for GE Medical Systems Information Technologies Inc

Recall: GE Medical Systems Information Technologies Inc — Class II recall: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph →

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: GE Healthcare Portrait Core Services SW V 1.2.0,… by GE Medical Systems Information Technologies Inc. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/ge-medical-systems-information-technologies-z-2878-2026-2026-08-12

MLA

"Recall Record: Class II Recall: GE Healthcare Portrait Core Services SW V 1.2.0,… by GE Medical Systems Information Technologies Inc." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/ge-medical-systems-information-technologies-z-2878-2026-2026-08-12.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: GE Healthcare Portrait Core Services SW V 1.2.0,… by GE Medical Systems Information Technologies Inc." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/ge-medical-systems-information-technologies-z-2878-2026-2026-08-12.

BibTeX

@misc{argushq_argushq_ai_recall_ge_medical_systems_information_technologies_z_2878_2026_2026_08_12_2026,
  title = {Recall Record: Class II Recall: GE Healthcare Portrait Core Services SW V 1.2.0,… by GE Medical Systems Information Technologies Inc},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/ge-medical-systems-information-technologies-z-2878-2026-2026-08-12},
  note = {Accessed: August 27, 2026}
}

Source: FDA.gov — Recalls ↗