GE recalls

GE HealthCare found a nonconformance in certain Senographe Pristina VIA systems. In 3D+2D manual mode, when the anode track and filter combination is configured differently, the collimator blades might show in the image or the collimator might open more than expected, and the wrong collimator filter might be used for the selected anode track. This could deliver a minor additional X-ray dose to the patient and cause obvious image artifacts.

Moderate·FDA·Nov 4, 20263 products

GE's Carescape Central Station patient monitoring system may take up to 3 minutes to resume monitoring after a restart. During this gap, clinically important changes in a patient's condition might not be detected right away.

Moderate·FDA·Sep 23, 2026

GE is recalling four Portrait Core Services software products because a software issue may cause a loss of patient monitoring at the Hub and Central Viewer. After the update, alarm settings may also reset to factory defaults and no longer match the settings configured for each patient or care area. No injuries have been reported.

Serious·FDA·Sep 2, 20264 products

GE Healthcare recalled certain MAC VU360 electrocardiograph units running software v3.0. After the order refresh icon is selected, a preview or review screen may not close automatically after 2 minutes of inactivity, so data from a previous patient could stay on screen and be linked to the next patient. No injuries have been reported.

Moderate·FDA·Aug 12, 2026

GE HealthCare found that some Optima XR200, XR220, and XR240amx mobile X-ray systems that had a column replacement may not have had their safety pawl tested to confirm proper assembly. If the internal counterpoise cable fails, the column safety mechanism may not work, and the X-ray tube and collimator arm could drop down the column during an exam. The recall covers 66 units across three products. No injuries have been reported.

Moderate·FDA·Jul 22, 20263 products

GE Healthcare's AW Server 3.2 ext.6.5 has a software issue that can cause the system to display a previous patient's medical images instead of the correct patient's images when launching certain applications. There is no warning or error message when this happens. If a radiologist or clinician does not notice the error, they could misread images, make wrong diagnoses, or recommend incorrect treatment.

Moderate·FDA·Jul 1, 2026

GE HealthCare is recalling three Giraffe OmniBed product lines, about 43,300 units in total, used as infant incubators and warmers. Under certain conditions, such as impact during transport, fasteners holding the canopy soffit beneath the control panel can come loose, and a fastener could fall into the patient compartment. In rare cases, the canopy soffit could become loose or detach, which could potentially injure a patient. No injuries have been reported.

Moderate·FDA·Jun 24, 20263 products

GE HealthCare found a possible problem with an electrical cable in certain Allia IGS X-ray systems that use Gaia generators. The issue could expose service personnel to electrical shock while working inside the C-FRT cabinet with power on. This recall includes 5 product lines, with 173 affected units in total.

Moderate·FDA·Jun 17, 20265 products

GE HealthCare recalled six ApexPro CARESCAPE Telemetry Server products and related software. A persistent NO COMM or OFF NETWORK condition at the Central Station could cause loss of ECG and SpO2 monitoring. No injuries have been reported.

Serious·FDA·Jun 3, 20266 products

GE HealthCare found a potential security weakness in AW Server, a software application used with certain Revolution CT scanners through the Edison Health Link CT Smart Subscription. This recall covers 7 CT scanner products, with 146 units affected in total. No injuries have been reported.

Moderate·FDA·May 20, 20267 products

GE Medical Systems' Imactis CT-Navigation System (Models E85101LA and E85101LP) has a potential issue where the needle's simulated path shown to the doctor may not match where the needle actually goes during CT-guided procedures. This discrepancy could affect the accuracy of needle placement during medical procedures. No injuries have been reported.

Moderate·FDA·Apr 1, 2026

GE is recalling three versions of Centricity Universal Viewer software, a program that displays medical images, including mammograms. User login credentials may be exposed on the local workstation, which could let an unauthorized person affect system availability or manipulate data. The recall covers 2,405 affected units, and no injuries have been reported.

Moderate·FDA·Mar 25, 20263 products

GE Healthcare is recalling certain Carestation 600 and 700 Series anesthesia systems, along with a related power management board part, because they may unexpectedly shut down if AC power is unplugged or lost. These systems have no continuous backup power and do not automatically switch to battery, so they reboot and may briefly interrupt ventilation and anesthetic delivery without returning to previous settings. The recall covers 3 product entries with about 2,368 units affected, and no injuries have been reported.

Serious·FDA·Dec 24, 20253 products

Some GE Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems were distributed with a missing or incorrect X-ray warning label. This label is required by federal regulation to inform users of radiation hazards. No injuries have been reported.

Moderate·FDA·Dec 17, 2025