Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

• • 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.

Trade Name

Vivid E80 EUDAMED

Vivid GUDID

Generic Name

Cardiovascular ultrasound imaging system

Model / Reference

Vivid E95_Vivid E90_Vivid E80 EUDAMED

Vivid E80 v206 EUDAMED

E80 v206 GUDID

Primary DI / UDI-DI

00195278505347

Basic UDI-DI

8406821BUG00253HB

Direct Marketing DI

00195278505347

510(k) Number

K150087 ↗ 510(k)

K220882 ↗ GUDID

FDA Product Code

IYN, ITX, OBJ, IYO

EMDN Code

Z11040102 Cardiology ultrasound scanners

GMDN Term

Cardiovascular ultrasound imaging system

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1550 510(k)GUDID

892.1570 GUDID

870.1200 GUDID

892.1560 GUDID

Market of Registration

Norway

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Unsafe

• Ge Vivid E9 Diagnostic Ultrasound Imaging System

  Class II

  FDA 510(k) K101149 Active Cleared 13 Oct 2010

• 6VT-D Ultrasound Transducer

  Class II

  CE/MDR FDA 510(k) K141093 Active Cleared 15 May 2014

• Ge Echopac Model BT10

  Class II

  FDA 510(k) K101324 Active Cleared 5 Oct 2010

• Ge Vscan Compact Diagnostic Ultrasound System

  Class II

  FDA 510(k) K092756 Active Cleared 28 Sep 2009

• P2D

  Class IIa

  CE/MDR GUDID on market

• Vivid E95

  Class IIa

  CE/MDR GUDID on market

See all devices from GE Vingmed Ultrasound AS →

• Are these ultrasound systems designed for single-use or reusable in clinical settings, and what cleaning requirements apply?

  The Vivid E80, E90, and E95 are reusable medical devices intended for repeated use in clinical environments like hospitals and outpatient clinics. Since they are not sterile, they must undergo proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality. The manufacturer’s instructions outline specific protocols to follow.

• What regulatory pathways have these ultrasound systems undergone, and which advisory committee was involved?

  The Vivid E80, E90, and E95 systems are FDA 510(k) cleared under the Radiology Advisory Committee (RA) as substantially equivalent devices. They also comply with the EU Medical Device Regulation (MDR). The FDA submission was filed in 2015 under K150087 and received clearance on March 4, 2015.

• How do the Vivid E80, E90, and E95 differ in terms of performance and transducer options?

  While the exact performance specifications and transducer configurations vary by model, the Vivid E80, E90, and E95 are designed for high-resolution imaging across specialties like cardiology, obstetrics, and radiology. The manufacturer’s documentation details the differences in imaging capabilities, transducer types, and advanced algorithms for each system, ensuring tailored use for clinical needs.

• What types of clinical settings are these ultrasound systems intended for, and why?

  These systems are intended for hospitals, outpatient clinics, and emergency departments due to their portable design and advanced imaging capabilities. Their real-time visualization and high-resolution cross-sectional imaging support diagnostic workflows in dynamic environments where flexibility and reliability are critical.