Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; ... — FDA record Z-2652-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
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.
Classification
Class II
Recalling firm
GE MEDICAL SYSTEMS, ISRAEL LTD.
Quantity
5986 devices
Agency-reported status
Ongoing
Source record identifier
Z-2652-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityVenue 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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Oct 11, 2023
Recall initiation date
Sep 6, 2023
Center classification date
Sep 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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