Z-2652-2023 Class II Ongoing

Recalled by GE MEDICAL SYSTEMS, ISRAEL LTD. — HAIFA, N/A

Recall Details

Product Type
Devices
Report Date
October 11, 2023
Initiation Date
September 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5986 devices

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.

Distribution Pattern

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

Code Information

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