Recall Z-2125-2023— GE Vingmed Ultrasound As

Name: FDA recall Z-2125-2023
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 one FDA 510(k) clearance: K142323. Product: GE Healthcare Vivid S70, 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

1 on FDA's record

K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel , Ltd.·cleared 2014-10-10

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 S70, 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.