4V-D

• FDA 510(k) K150087 decided 4 Mar 2015 Active
• FDA GUDID UDI-DI 00840682107075 listed 15 Jul 2016 Listed

• • 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.

1. 4 Mar 2015 Cleared FDA 510(k) K150087
2. 15 Jul 2016 Listed FDA GUDID 00840682107075
3. 10 Mar 2017 Recall initiated FDA recalls Z-1780-2017
4. 10 Mar 2017 Recall initiated FDA recalls Z-1779-2017
5. 22 Mar 2018 Recall initiated FDA recalls Z-2986-2018
6. 22 Mar 2018 Recall initiated FDA recalls Z-2988-2018
7. 22 Mar 2018 Recall initiated FDA recalls Z-2987-2018
8. 2 May 2024 Recall initiated FDA recalls Z-2316-2024

Generic name

Extracorporeal ultrasound imaging transducer, hand-held

Model / reference

4V-D

Primary DI / UDI-DI

00840682107075

510(k) Number

K150087 ↗

FDA product code

IYN, IYO, ITX

GMDN term

Extracorporeal ultrasound imaging transducer, hand-held

Device class

Class II

Regulation number

892.1550, 892.1560, 892.1570

GUDID distribution status

In Commercial Distribution

Category: Extracorporeal ultrasound imaging transducer, hand-held

Other devices filed under Extracorporeal ultrasound imaging transducer, hand-held.

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• mC 3-11 120000046 by Esaote S.p.A.
• C252 04573596211342 by FUJIFILM CORPORATION
• L4-12t-RS H48062AB by GE Medical Systems CO. Ltd
• IC10-3 P23121-23A by Fujifilm Sonosite, Inc.
• C3-10-D by GE HEALTHCARE JAPAN CORPORATION
• LA435 9600173000 by Esaote S.p.A.
• L10-5v Transducer 11319682 by SIEMENS MEDICAL SOLUTIONS USA, INC.
• ML6-15-RS by GE HEALTHCARE JAPAN CORPORATION
• C253 04573596211359 by FUJIFILM CORPORATION

• 4C

  Class II

  FDA 510(k) ×2 Active Cleared 21 Oct 2003 GUDID on market

• 8l-Rs Open recall

  Class II

  FDA 510(k) K121063 Active Cleared 21 Aug 2012 GUDID on market

• 7S-Rs Open recall

  Class II

  FDA 510(k) K121063 Active Cleared 21 Aug 2012 GUDID on market

• 4C-Rs Open recall

  Class II

  FDA 510(k) ×2 Active Cleared 26 Apr 2016 GUDID on market

See all devices from GE Parallel Design, Inc. →