Ge Medical Systems Scs
283 RUE DE LA MINIERE, BUC, FR
Registered product codes
19 product codes
Recent MDR events
507 on file
- ALLIAJun 26, 2026Injury9611343-2026-00002
- INNOVAApr 17, 2026Malfunction9611343-2026-00001
- INNOVANov 21, 2025Injury9611343-2025-00012
- INNOVA 4100Nov 14, 2025Death9611343-2025-00011
- INNOVASep 23, 2025Malfunction9611343-2025-00010
- INNOVAJul 11, 2025Malfunction9611343-2025-00008
- INNOVA IGS 520 OMEGAMay 7, 2025Malfunction9611343-2025-00007
- INNOVA 4100Apr 14, 2025Injury9611343-2025-00006
- DISCOVERYMar 21, 2025Malfunction9611343-2025-00005
- INNOVAMar 13, 2025Injury9611343-2025-00004
Recalls
13 on file
- Open, ClassifiedJun 24, 2026
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.
View FDA record ↗ - Open, ClassifiedOct 8, 2025
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedMay 6, 2024
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.
View FDA record ↗ - Open, ClassifiedFeb 8, 2024
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
View FDA record ↗
Compliance history
Matched by FEI 1000284313.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.