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GE Medical Systems SCS

France FR-MF-000000687 Last updated 25 Oct 2026

Devices
172
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
1310 ongoing

Catalogue172

Page 1 of 4

Showing 1-50 of 172

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

GMED SAS 0459 1 certificate

  • 38746 Supplemented

    Quality management system EU MDR

    Issued
    13 Oct 2026
    Expires
    15 Apr 2031
    Reason
    Change approved

Related companies

Notified bodies

FDA recalls13

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

GE Medical Systems SCS has 12 FDA recall records initiated between March 29, 2018, and September 5, 2025. The records include open, classified, and terminated statuses, with reasons involving technical malfunctions such as X-ray abort errors on imaging systems, a security vulnerability in AW Server products affecting patient data, an intermittent audible signal failure on the Senographe Pristina, and potential adhesive application issues on certain bolts of multiple IGS product models that could impact detector or X-ray tube stability.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 13 recalls.

  • 2026

    • 8 May 2026 Z-2553-2026 Class II Ongoing 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.

  • 2025

    • 5 Sep 2025 Z-0068-2026 Class II Ongoing 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.

  • 2024

    • 18 Mar 2024 Z-1777-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1778-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1779-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1780-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1781-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1782-2024 Class II Ongoing 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.
    • 18 Mar 2024 Z-1783-2024 Class II Ongoing 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.

  • 2023

    • 26 Dec 2023 Z-0862-2024 Class II Ongoing X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Show all 13 recalls

  • 2018

    • 29 Mar 2018 Z-2386-2018 Class II Terminated 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.
    • 29 Mar 2018 Z-2387-2018 Class II Terminated 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.
    • 29 Mar 2018 Z-2388-2018 Class II Terminated 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.

What GE Medical Systems SCS makes

GE Medical Systems SCS develops imaging software and analysis tools for cardiovascular, neurological, and musculoskeletal diagnostics. Their portfolio includes embolization planning systems like *FlightPlan*, cardiac imaging solutions such as *CardEP* and *CardIQ Fusion PET*, and advanced CT analysis tools like *AdvantageCTC Pro3D EC* and *TAVI Analysis*. Other offerings include radiation dose monitoring (*DoseWatch*), bone density assessment (*Bone VCAR*), and workflow management software (*GSI Viewer*).

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, with corresponding listings in the EUDAMED database and FDA’s 510(k) registry. The manufacturer is based in France and adheres to regulatory requirements for software-as-a-medical-device (SaMD) and imaging systems.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does GE Medical Systems SCS manufacture?

GE Medical Systems SCS specializes in imaging software and diagnostic analysis tools. Their portfolio includes embolization planning systems like *FlightPlan*, cardiac imaging solutions such as *CardEP* and *CardIQ Fusion PET*, advanced CT analysis tools like *AdvantageCTC Pro3D EC* and *TAVI Analysis*, radiation dose monitoring software (*DoseWatch*), bone density assessment tools (*Bone VCAR*), and workflow management software (*GSI Viewer*). These devices are designed to support cardiovascular, neurological, and musculoskeletal diagnostics.

Where is GE Medical Systems SCS based, and what regulatory regions do their devices serve?

GE Medical Systems SCS is based in France. Their devices are listed in the EUDAMED database under the EU Medical Device Regulations and in the FDA’s 510(k) registry, indicating compliance with both European and U.S. regulatory requirements for medical devices.

How are the devices manufactured by GE Medical Systems SCS classified under EU regulations?

The devices produced by GE Medical Systems SCS fall under four EU Medical Device Regulation classifications: Class I, Class II, Class IIa, and Class IIb. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety, with higher classes (e.g., Class IIb) requiring stricter regulatory scrutiny due to increased risk.

Are the devices from GE Medical Systems SCS listed in any public regulatory registries?

Yes, the devices manufactured by GE Medical Systems SCS are listed in two key public registries: the EUDAMED database, which tracks medical devices authorized under EU regulations, and the FDA’s 510(k) registry, which documents devices cleared for marketing in the United States. These listings provide transparency on their regulatory status.

What distinguishes the software-based devices from GE Medical Systems SCS in terms of regulatory classification?

The software-based devices from GE Medical Systems SCS, such as *FlightPlan* or *DoseWatch*, are classified as software-as-a-medical-device (SaMD) under EU regulations. Their classification—ranging from Class I to Class IIb—depends on the device’s intended purpose and risk profile, with higher classes assigned to software that directly influences clinical decisions or patient management, requiring additional validation and compliance measures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
France(from SRN)
Address
2, Rue Marie Hamm, Strasbourg, France
PRRC contact
Camille Vidal
EUDAMED SRN
FR-MF-000000687
FDA FEI number
1000284313