FDA DeviceClass IINotable

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

Date: 2026-08-12
Brand: GE Medical Systems Information Technologies Inc
Category: Medical Device
FDA Class: Class II

Description

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).

Hazard

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).

Remedy

11 units

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