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9T-Rs

by GE Vingmed Ultrasound AS Norway EUDAMEDGUDID

Ref KN100122Model 9T

Product code IYOEMDN Z1104020302

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00006GQ Basic UDI-DIDate8 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682115728 UDI-DIDate15 Jul 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2316-2024 FDA Class II initiated 2 May 2024

    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.

  • 3 recalls, same reason

    • Terminated Z-2986-2018 FDA Class II initiated 22 Mar 2018
    • Terminated Z-2988-2018 FDA Class II initiated 22 Mar 2018
    • Terminated Z-2987-2018 FDA Class II initiated 22 Mar 2018

    The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

  • 2 recalls, same reason

    • Terminated Z-1780-2017 FDA Class II initiated 10 Mar 2017
    • Terminated Z-1779-2017 FDA Class II initiated 10 Mar 2017

    GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
9T-Rs EUDAMED
Na GUDID
Generic Name
Oesophageal ultrasound imaging transducer, reusable
Device Name
9T
Model / Reference
9T EUDAMED
KN100122 EUDAMED
9T-RS GUDID
Primary DI / UDI-DI
00840682115728
Basic UDI-DI
8406821BUG00006GQ
510(k) Number
FDA Product Code
IYO, ITX, IYN
EMDN Code
Z1104020302 Transesophageal ultrasound probes, multidimensional
GMDN Term
Oesophageal ultrasound imaging transducer, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560, 892.1570, 892.1550
Market of Registration
Norway
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
9T
KN100122
GUDID
9T-RS
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-MF-000000553

Other devices from Ge Vingmed Ultrasound

See all devices from Ge Vingmed Ultrasound →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (2)

  • EUDAMED a1585235-54ea-4418-8816-e25ee127176a 61 fields · synced 24 Oct 2026
  • FDA UDI 51c558cd-b3af-4aa6-bb14-939240027014 34 fields · synced 30 May 2026