Manufacturer

GE Medical Systems, LLC

113 recalls in our database name GE Medical Systems, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 113

ModerateFDA (Devices)·Z-2151-2026·2026-05-20
Revolution Apex Elite X-ray CT System Security Vulnerability Recall
GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.
Product
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2150-2026·2026-05-20
Revolution CT X-ray Computed Tomography System Security Vulnerability Recall
GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.
Product
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2152-2026·2026-05-20
Revolution Apex Plus CT System Security Vulnerability Recall
GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected worldwide.
Product
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2153-2026·2026-05-20
Revolution CT ES X-ray Computed Tomography System Security Vulnerability Recall
GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.
Product
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2149-2026·2026-05-20
Revolution Ascend CT scanner security vulnerability affecting AW Server
GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.
Product
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2155-2026·2026-05-20
Revolution Apex Select CT systems subject to software security vulnerability recall
GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.
Product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2154-2026·2026-05-20
Revolution Apex X-ray CT System Security Vulnerability Recall
GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.
Product
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2026·2026-04-01
CT-Navigation System may display inaccurate needle positioning guidance
GE Medical Systems is recalling 125 units of the Imactis CT-Navigation System because the displayed needle position may not match the actual needle trajectory during CT-guided procedures.
Product
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1569-2026·2026-03-25
Centricity Universal Viewer Medical Imaging Software Has Credential Exposure Vulnerability
Centricity Universal Viewer versions 7.0 through 7.0 Sp2.0.1 contains a cybersecurity vulnerability that may expose login credentials on workstations, potentially allowing unauthorized access to medical imaging systems.
Product
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1570-2026·2026-03-25
Centricity Universal Viewer software cybersecurity vulnerability may expose login credentials
Centricity Universal Viewer Software versions 6.0 through 6.0 Sp10.4.1 contain a cybersecurity vulnerability that could expose user login credentials on affected workstations, potentially allowing unauthorized access to medical imaging data and systems.
Product
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 210
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1571-2026·2026-03-25
Medical device software cybersecurity vulnerability exposes user credentials
Centricity Universal Viewer Software has a cybersecurity vulnerability that may expose user login credentials on workstations. Unauthorized individuals could impact system availability or manipulate medical data.
Product
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0875-2026·2025-12-17
Mammography Systems Recall: Missing or Incorrect X-Ray Warning Labels
GE Medical Systems is recalling certain Senographe mammography systems due to missing or incorrect X-Ray warning labels. The recall affects approximately 1,818 units globally.
Product
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0231-2026·2025-10-29
Electrocardiograph Cable Risk from Improper Module Placement
GE Medical Systems is recalling MAC VU360 Acquisition Trunk Cables for potential overheating if modules are placed incorrectly. Damaged cables expose wires and may overheat during continued use, creating a fire hazard.
Product
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2026·2025-10-22
Ultrasound system may display inaccurate liver steatosis measurements
GE Medical Systems is recalling LOGIQ P10 series ultrasound systems because the liver steatosis measurement feature may display inaccurate values, potentially leading to incorrect clinical decisions.
Product
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2026·2025-10-22
GE LOGIQ P9 Ultrasound System Software Displays Inaccurate Liver Steatosis Measurements
GE Medical Systems is recalling 37 LOGIQ P9 R4.5 ultrasound systems because the UGAP measurement feature may display inaccurate values for liver steatosis, potentially leading to inappropriate clinical decisions.
Product
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2026·2025-10-22
Ultrasound System May Display Inaccurate Liver Steatosis Measurement Values
GE Medical Systems' LOGIQ P10 R4.5 HD ultrasound system may display inaccurate liver steatosis measurements, potentially leading to inappropriate clinical decisions.
Product
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2025·2025-09-03
GE HealthCare OEC C-arm Systems recalled for missing radiation shielding
GE HealthCare is recalling certain OEC 9800 and OEC 9900 Elite C-arm Systems due to missing lead tape in collimator covers, which increases radiation exposure to patients and operators.
Product
GE HealthCare OEC 9900 Elite C-arm Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2025·2025-09-03
GE HealthCare OEC C-Arm Systems: Missing Lead Shielding Increases Radiation Exposure
GE Medical Systems is recalling certain OEC 9800 and OEC 9900 Elite C-arm systems with missing lead tape in collimator covers, causing small increases in radiation exposure to patients and operators. The defect is not detectable by users.
Product
GE HealthCare OEC 9800.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2025·2025-08-20
GE MR Systems Patient Table Caster Lock Maintenance Recall
GE HealthCare is recalling certain MR imaging systems because planned maintenance steps to verify caster lock functionality on the patient table may not have been completed.
Product
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2300-2025·2025-08-20
GE Medical MRI Systems Caster Lock Maintenance Check Recall
GE HealthCare is recalling certain MRI systems because planned maintenance checks on caster lock functionality may not have been performed on some units. Approximately 280 systems are affected, with worldwide distribution.
Product
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2315-2025·2025-08-20
GE SIGNA MR Systems Caster Lock Maintenance Verification Not Completed
GE HealthCare identified that maintenance steps to verify caster lock functionality on certain SIGNA MR patient tables may not have been performed. Affected healthcare facilities should contact GE HealthCare to verify their systems.
Product
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2313-2025·2025-08-20
GE HealthCare MRI Systems Caster Lock Maintenance Verification Recall
GE HealthCare recalled certain MRI systems after discovering that planned maintenance checks to verify caster lock functionality on patient tables may not have been performed on some units.
Product
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2303-2025·2025-08-20
GE SIGNA MRI Systems Patient Table Caster Lock Maintenance Not Verified
GE HealthCare recalled 758 units of SIGNA and related MRI systems worldwide because maintenance checks on patient table caster locks may not have been performed, creating risk of unwanted table movement during imaging.
Product
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2307-2025·2025-08-20
GE Discovery MR750w MRI system caster lock maintenance checks incomplete
GE recalled Discovery MR750w MRI systems where planned maintenance checks for caster lock functionality may not have been performed. This affects 519 units distributed worldwide.
Product
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2310-2025·2025-08-20
MR Imaging System Caster Lock Maintenance May Not Have Been Performed
GE HealthCare recalls certain MR imaging systems where planned maintenance checks on patient table caster locks may not have been performed. The recall affects systems that received maintenance since March 1, 2023.
Product
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states