FDA-Device2023-07-19Class II

GE Healthcare Vivid S60, 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
2 units
Manufactured in
Strandpromenaden 45, N/A, Horten, N/A, Norway
Products
GE Healthcare Vivid S60, ultrasound device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2023

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