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Na 6VT-D

by GE Vingmed Ultrasound A/S

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682115650 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2317-2024 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.

  • 2 recalls, same reason

    • Ongoing Z-2124-2023 FDA Class II initiated 30 May 2023
    • Ongoing Z-2125-2023 FDA Class II initiated 30 May 2023

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Oesophageal ultrasound imaging transducer, reusable
Model / Ref / Catalog
6VT-D, KN100120
Primary DI / UDI-DI
00840682115650
510(k) Number
FDA Product Code
ITX, IYO, IYN
GMDN Term
Oesophageal ultrasound imaging transducer, reusable
Device Class
Class II
Regulation Number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oesophageal ultrasound imaging transducer, reusable

Cleared under the same submission (K142323)

Other devices from GE Vingmed Ultrasound A/S

See all devices from GE Vingmed Ultrasound A/S →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No