Recall Z-2652-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
| Date | Sep 29, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated 9/6/2023 via FedEx in the U.S. which explained the safety issue and actions to be taken by the customer/user. The actions included: On a weekly basis, check the vertical/horizontal tilt adjustment mechanism on the Venue Go Standard Cart to ensure it is secure: (1) Lock the wheels; (2) Raise the up/down adjustment column to its highest position; (3) Observe the tilt mechanism during side-to-side rocking as is shown in the photos in the letter. If the vertical/horizontal tilt adjustment mechanism is loose, the consignee is to (1) remove the Venue Go sy |
| Quantity | 5986 devices |
| Distribution | Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR. |
| FDA record | Open on fda.gov |