Device 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
Z-2652-2023
Product summary
- Event
- Event 93069
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5986 devices
- Official record key
device-enforcement:Z-2652-2023
Official wording
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.
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
Distribution pattern: Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Derived failure modes
-
Unknown
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.