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GE Medical Systems SCS

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000000687 FEI 1000284313

Devices
172
Registrations
EUDAMEDFDA
FDA recalls
1310 ongoing

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue172

Newest first, rows 51-100 of 172

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  • CT Perfusion 4D Neuro Ref 5854353

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Igs 5 Ref 5943307

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • CT Perfusion 4D Ref 5940383

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EVARVision Ref 5853526

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • DynamicIQ Ref 5971001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AdvantageCTC Pro3D EC Ref 5976260

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Colon VCAR EC Ref 5976259

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FlightPlan for EVAR Ref 5976264

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Pet Vcar Ref 5970989

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • 3DXR Ref 5967424

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • AdvantageCTC Pro3D EC Ref 5934733

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • PROView Ref 5970991

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Volume Viewer Ref 5854374

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Thoracic VCAR Ref 5970995

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Hepatic VCAR Ref 5854360

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Lung VCAR Ref 5976271

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Colon VCAR EC Ref 5854350

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Pristina Via Ref 5969633

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Thoracic VCAR Ref 5976281

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Pristina Serena Ref 7201138-2

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Vision 2 Ref 5853351

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • CardIQ Function Xpress Ref 5934728

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AutoBone Xpress Ref 5934724

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • HeartVision 2 Ref 5853525

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • CardIQ Function Xpress Ref 5976255

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • DynamicIQ Ref 5882427

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • CardIQ Flow Ref 5970970

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Pet Vcar Ref 5854365

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FlightPlan for Embolization Ref 5970979

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MR VesselIQ Xpress Ref 5934748

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Moveo Ref 5981876 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • Pristina Via Ref 5993837

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Integrated Registration Ref 5854361

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Liver Suite Ref 5976270

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • VesselIQ Xpress Ref 5976282

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Thoracic VCAR Ref 5934753

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • GSI Viewer Ref 5970983

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FlightPlan for EVAR Ref 5970980

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AdvantageCTC Pro3D EC Ref 5970976

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • OncoQuant Ref 5976272

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Volume Viewer Ref 5976283

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AW Server (version: 3.2) Ref 5719780

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • PROView Ref 5976275

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • FlightPlan for Embolization Ref 5854355

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • CT Perfusion 4D Ref 5976261

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • CardIQ Xpress 2.0 Ref 5854349

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Volume Viewer Innova Ref 5976285

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • CardIQ Xpress 2.0 Ref 5976258

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Hepatic VCAR Ref 5976268

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • CardIQ Flow Ref 5934727

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 51-100 of 172

Showing 51-100 of 172

Company details

EUDAMED SRN
FR-MF-000000687
FDA FEI number
1000284313
EU VAT number
FR 32315013359
EUDAMED status
Active
EUDAMED registered name
GE Medical Systems SCS
EUDAMED abbreviated name
GE HEALTHCARE
Registered address
283, Rue de la Miniere, 78530, BUC, France
PRRC contact
Gregory Pessato(public in EUDAMED)
1 more person
  • Camille Vidal

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 15 Apr 2031

EUDAMED certificates (1)

GMED SAS 0459 1 certificate

  • 38746 Active Supplemented

    Quality management system EU MDR

    Issued
    13 Oct 2026
    Expires
    15 Apr 2031
    Reason
    Change approved

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by GE Medical Systems SCS, the earliest on 2018-03-29 and the most recent on 2026-05-08. By recorded status: 10 ongoing and 3 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 3
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 1
  • 2024 7
  • 2025 1
  • 2026 1

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. Distribution: Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin,…
      Full distribution text Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.
      Submission number: K081985

  • 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. Distribution: Domestic US distribution nationwide. International distribution worldwide. Submission number: K081985

  • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K181403
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K181403
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K232344
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K232344
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K232344
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K181403
    • 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. Distribution: Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of…
      Full distribution text Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
      Submission number: K181403

  • 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. Distribution: Us Nationwide-Worldwide Distribution Submission numbers: K162268, K182951, K193334, K211215, K173576
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. Distribution: US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution:…
      Full distribution text US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.
      Submission numbers: K122457, K113403
    • 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. Distribution: US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution:…
      Full distribution text US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.
      Submission numbers: K111209, K122457
    • 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. Distribution: US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution:…
      Full distribution text US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.
      Submission number: K133278

Frequently asked questions

How many devices does GE Medical Systems SCS have in the registry?

The registry currently lists 172 devices for GE Medical Systems SCS. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for GE Medical Systems SCS?

FDA recall records list 13 recalls initiated by GE Medical Systems SCS, the most recent initiated on 8 May 2026. 10 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for GE Medical Systems SCS?

EUDAMED lists 1 certificate for GE Medical Systems SCS (quality management system) under MDR. The most recent was issued on 13 Oct 2026.

Generated automatically from registry data and not verified by a human reviewer.