FDA-Device2023-07-19Class II
GE Healthcare Vivid S60N, ultrasound device
GE Vingmed Ultrasound As
Hazard
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.
Sold states
Worldwide distribution.
Affected count
N/A
Manufactured in
Strandpromenaden 45, N/A, Horten, N/A, Norway
Products
GE Healthcare Vivid S60N, ultrasound device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2023Don't want to check this manually?
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