FDA recall Z-2652-2023

Product

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.

Distribution

Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.

Key facts

Status

Ongoing

Initiation date

2023-09-06

Report date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

HAIFA, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2652-2023