Recall Z-2126-2023— GE Vingmed Ultrasound As

Name: FDA recall Z-2126-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-30

Class II · Ongoing

Class II FDA medical device recall by GE Vingmed Ultrasound As, initiated 2023-05-30. It names 6 FDA 510(k) clearances: K223832, K220619, K211216 and 3 more. Product: GE Healthcare Vivid S60N, ultrasound device. Reason: 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..

Recalling firm: GE Vingmed Ultrasound As
Classification: Class II
Status: Ongoing
Initiated: 2023-05-30
Firm location: Horten, N/A, Norway

510(k) clearances named in this recall

6 on FDA's record

K223832 — Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics·cleared 2023-02-16
K220619 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2022-07-15
K211216 — Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2021-06-09
K200497 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2020-07-16
K182450 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2018-10-19
K170878 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC·cleared 2017-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Vivid S60N, ultrasound device

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.