GE

GE HealthCare identified that some Optima XR200/220/240amx systems that underwent column replacement may not have had proper safety testing completed. If an internal cable fails, the safety mechanism could malfunction, allowing the X-ray arm to drop unexpectedly during patient exams.

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.

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed infant beds. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners disengaging could cause the canopy soffit to loosen or detach entirely.

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed Carestations. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners may disengage, causing the canopy soffit to loosen or detach.

GE HealthCare identified a potential problem with fasteners that secure the canopy soffit (the cover beneath the control panel) on Giraffe OmniBed infant incubators and warmers. During transport or impact, one or more of these fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners can disengage, causing the soffit to become loose or detach.

GE HealthCare identified a potential electrical cable issue on certain Allia Moveo angiographic X-ray systems equipped with Gaia generators. Service personnel who work inside the equipment cabinet while power is on could be exposed to electrical shock during installation, maintenance, or troubleshooting.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while power is on could be exposed to electrical shock.

GE HealthCare identified a faulty electrical cable on certain Allia IGS 7 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel working inside the C-FRT cabinet while the system is powered on could receive an electrical shock during installation, maintenance, or troubleshooting.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 5 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on face a risk of electrical shock.

GE HealthCare identified a potential electrical cable issue on certain Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators. Service personnel performing installation, maintenance, or troubleshooting work inside the C-FRT cabinet while the system is powered on could be at risk of electrical shock.

GE HealthCare has identified a situation where the ApexPro CARESCAPE Telemetry Server (versions 5.0 and 6.0) can lose ECG and SpO2 monitoring data if the system loses network connection to the central monitoring station. This affects 14 units used in hospitals and clinical settings.

GE HealthCare identified a rare condition in CARESCAPE Telemetry Server v5.0 and v6.0 where a persistent network communication failure at the central monitoring station can result in loss of ECG and SpO2 (heart rhythm and blood oxygen) monitoring. The problem occurs only when the system is in a "NO COMM" or "OFF NETWORK" state at the central station.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the server. No injuries have been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 10 units distributed nationwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 11 units worldwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through the Edison Health Link subscription service. The vulnerability could potentially allow unauthorized access to the system. No patient harm has been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution CT, Revolution Apex, and Revolution Ascend CT scanners deployed through Edison Health Link (EHL). The vulnerability could potentially allow unauthorized access to the system. This affects 38 units worldwide.

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.

GE Medical Systems' Centricity Universal Viewer software versions 5.0 SP6 through 5.0 SP7.1 has a cybersecurity weakness that may expose user login credentials on affected workstations. An unauthorized person could potentially use these exposed credentials to access the system, disrupt service, or alter medical images and data.

Certain versions of GE Centricity Universal Viewer software (versions 6.0 through 6.0 Sp10.4.1) contain a cybersecurity vulnerability that may expose user login credentials on affected workstations. An unauthorized person could potentially access the system and interfere with medical imaging data or system availability.

Certain versions of GE Centricity Universal Viewer software (versions 7.0 through 7.0 Sp2.0.1) contain a cybersecurity vulnerability that may expose user login credentials on workstations. An unauthorized person could potentially access the system and disrupt service or alter medical image data.

GE Healthcare has recalled certain Power Management Boards in Carestation 600 and 700 Series anesthesia systems. If AC power is lost or unplugged, these systems may unexpectedly shut down instead of switching to battery backup, causing temporary disruption of ventilation and medication delivery. After restart, the system will not return to its previous settings.

GE Healthcare has recalled certain Carestation 750 anesthesia systems that may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system will not automatically switch to battery backup and will reboot, which can temporarily disrupt ventilation and medication delivery. After rebooting, the system does not return to its previous settings.

GE Healthcare's Carestation anesthesia systems (600 and 700 Series) may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system does not automatically switch to battery backup and will restart instead. During the restart, ventilation and anesthetic gas delivery may briefly stop, and the system will not return to previous ventilation settings after reboot.

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.