GE Vingmed Ultrasound As recalls GE Healthcare Vivid S60N, ultrasound device

Recall date

May 30, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2126-2023

FDA classification

Class II

Brand / firm

GE Vingmed Ultrasound As

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare Vivid S60N, ultrasound device