FDA-Device2023-10-11Class II
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
GE MEDICAL SYSTEMS, ISRAEL LTD.
Hazard
Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.
Sold states
Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Affected count
5986 devices
Manufactured in
Nativ Haa??or Street no. 1, N/A, HAIFA, N/A, Israel
Products
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2652-2023Don't want to check this manually?
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