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Recall Observatory FDA recall evidence

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

September 06, 2023

Class II

Product summary

Firm
GE MEDICAL SYSTEMS, ISRAEL LTD.
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

    reason.no_named_rule · v1.0.0

    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.