GE Healthcare recalls

GE Healthcare is recalling six medical imaging and archive software products, with about 4,000 systems affected. Under certain conditions, historical imaging data moved from an older system can be linked to the wrong patient, so studies or images may appear in another patient's record. No injuries have been reported.

Serious·FDA·Sep 23, 20266 products

GE Healthcare has recalled specific lots of Omnipaque (iohexol) injection, a contrast dye used in medical imaging, because some vials may contain visible particles. This could affect the safety of the procedure if the contaminated solution is used.

Moderate·FDA·Apr 15, 20262 products

GE Healthcare SIGNA Premier whole-body MRI scanners may have steel fittings instead of brass fittings on the magnet rear. During service work while the magnet is powered up, the magnetic field could pull on these steel parts, risking injury to technicians.

Moderate·FDA·Apr 8, 2026

GE Healthcare has identified a software issue in certain versions of its Centricity Universal Viewer Zero Footprint Client where patient information displayed in the viewer may not match the medical images being shown. This could occur in specific workflows on systems with Patient Timeline installed. The issue affects approximately 250 units.

Serious·FDA·Mar 11, 2026

Certain GE Healthcare Omni Legend PET scanners may occasionally produce streaking artifacts in scan images. This visual distortion appears as lines in the images displayed on the scanner console and could affect image quality used for clinical diagnosis.

Moderate·FDA·Jan 28, 2026

GE HealthCare is recalling four older nuclear medicine imaging systems, 60 units in total, that are past their end of guaranteed service. The systems may have been moved without proper detector support, which could stress the detector mounts and lead to a detector falling. No falls or injuries have been reported.

Serious·FDA·Jan 21, 20264 products

GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

GE Healthcare is recalling five patient monitor products because certain batteries can lose the ability to hold a charge and provide backup power. If that happens while a monitor is running on battery, patient monitoring can stop, which could delay noticing a change in a patient's condition. No injuries have been reported.

Moderate·FDA·Nov 19, 20255 products