FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2652-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-09-06
- Posted
- 2023-09-29
- Terminated
- not on file
- 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 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
- 5986 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K183362","K202233","K220800"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002973981
- Firm city
- HAIFA
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28