Z-2652-2023Class II

Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4...

Name: Z-2652-2023 Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4...
Creator: Ge Medical Systems, Israel Ltd.
Published: 2023-09-06
License: https://open.fda.gov/license/

GE Medical Systems, Israel Ltd. / initiated 2023-09-06 / Open, Classified / root cause: design

FDA source

GE MEDICAL SYSTEMS, ISRAEL LTD. began a recall of 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 on 2023-09-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2652-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-09-29
Recalling firm: GE Medical Systems, Israel Ltd.
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: design
FDA 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 system from the Cart cradle and place on a tabletop using the adjustable rear support stand; and (2) Do not use the Venue Go Standard Cart until the corrective action is performed by GE HealthCare. All potential users i the facility are to be made aware of the safety notification and recommended actions. An acknowledgement form was enclosed for completion and return to the firm. In addition, the letter provided specific affected product details along with photographs on how to identify the manufacture date on the Venue Go Standard Cart since the affected devices that were impacted were manufactured 2022-08 and before. GE HealthCare will correct all affected products and a representative will contact the consignee to arrange for correction.
Quantity in commerce: 5986 devices
Distribution: Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2652-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2652-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)