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GE Medical Systems SCS Recalls

13 recalls on record · July 18, 2018 to July 1, 2026 · Medical Devices

Recalls by year

18
24
25
26

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

July 1, 2026Medical DevicesFDA
GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Hazard: GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
October 15, 2025Medical DevicesFDA
GE Medical Systems, SCS recalls AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Hazard: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Innova IGS 5, computed tomography x-ray system
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
February 14, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls Senographe Pristina
Hazard: X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
July 18, 2018Medical DevicesFDA
GE Medical Systems, SCS recalls Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Hazard: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
July 18, 2018Medical DevicesFDA
GE Medical Systems, SCS recalls Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Hazard: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
July 18, 2018Medical DevicesFDA
GE Medical Systems, SCS recalls Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Hazard: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
GE Medical Systems SCS Recalls | RecallWatchUSA