GE MEDICAL SYSTEMS, ISRAEL LTD.: 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

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.

Details from the source

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. Quantity: 5986 devices Lot/code info: Venue Go Standard Carts, Ref: (H45181VC and H45103VCW) used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems (GTIN 0084068213884, 00840682190503, and 00195278516510) that were manufactured 2022-08 and before

UPC codes

0084068213884, 00840682190503, 00195278516510

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.