GE Vingmed Ultrasound AS
Active in EUDAMEDNorwayfrom SRN EUDAMED FDA SRN NO-MF-000000553 FEI 3033508292
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 66 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Ge Vivid E9 Diagnostic Ultrasound Imaging System Ref K101149
Regimes: 510(k) Registry: 510(k)6VT-D Ultrasound Transducer Ref K141093
Regimes: CE MDR 510(k) Registry: 510(k)Ge Vivid E9 Diagnostic Ultrasound Imaging System Ref K120201
Regimes: 510(k) Registry: 510(k)Ge Echopac Model BT10 Ref K101324
Regimes: 510(k) Registry: 510(k)Ge Vscan Compact Diagnostic Ultrasound System Ref K092756
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID
Ge Vivid E9 Diagnostic Ultrasound Imaging System Ref K131514
Regimes: 510(k) Registry: 510(k)P2D Ref TE100024
Regimes: CE MDR Registry: EUDAMEDGUDIDVivid E95 Ref Vivid E95 v206
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- NO-MF-000000553
- FDA FEI number
- 3033508292
- EU VAT number
- 938937583MVA
- EUDAMED status
- Active
- EUDAMED registered name
- GE Vingmed Ultrasound AS
- Registered address
- 45, Strandpromenaden, 3191, HORTEN, Norway
- [email protected]
- PRRC contact
- Jon Ronander
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 4
- 2024 2
- 2025 0
- 2026 0
2024
- 2 May 2024 Z-2316-2024 Class II Ongoing GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
- 2 May 2024 Z-2317-2024 Class II Ongoing GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
2023
- 30 May 2023 Z-2124-2023 Class II Ongoing GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- 30 May 2023 Z-2125-2023 Class II Ongoing GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- 30 May 2023 Z-2126-2023 Class II Ongoing GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- 30 May 2023 Z-2127-2023 Class II Ongoing GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Frequently asked questions
How many devices does GE Vingmed Ultrasound AS have in the registry?
The registry currently lists 9 devices for GE Vingmed Ultrasound AS. Devices recorded under merged duplicate company entries are counted once.
Which registries list GE Vingmed Ultrasound AS's devices?
Among its 9 most recently registered devices, GE Vingmed Ultrasound AS has devices listed in EUDAMED (3 devices), FDA 510(k) (7 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GE Vingmed Ultrasound AS's devices fall under?
Among its 9 most recently registered devices, the classes recorded for GE Vingmed Ultrasound AS's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for GE Vingmed Ultrasound AS?
FDA recall records list 6 recalls initiated by GE Vingmed Ultrasound AS, the most recent initiated on 2 May 2024. 6 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 are the newest devices from GE Vingmed Ultrasound AS in the registry?
The most recently registered devices listed for GE Vingmed Ultrasound AS include GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM, 6VT-D ULTRASOUND TRANSDUCER, GE ECHOPAC MODEL BT10 and GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM.