PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 11, 2023 Initiated: September 6, 2023 #Z-2652-2023

Product Description

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

Reason for Recall

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.

Details

Units Affected
5986 devices
Distribution
Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Location
HAIFA, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by GE MEDICAL SYSTEMS, ISRAEL LTD.. Units affected: 5986 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2652-2023.