Venue Go recallZ-2652-2023 · Ge Medical Systems, Israel Ltd. · initiated Sep 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ge Medical Systems, Israel Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2652-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 6, 2023
- Posted by the FDA
- Sep 29, 2023
- Recalling firm
- Ge Medical Systems, Israel Ltd.
- Quantity
- 5986 devices
- Product code
- IYN
- FDA submissions
- K183362, K202233, K220800
- Distribution
- Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Venue Go R4GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC · System, imaging, pulsed doppler, ultrasonic2 recalls0 reports
- Venue Go R3GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC · Transducer, ultrasonic, diagnostic2 recalls0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K183362, K202233, K220800 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Venue Go R2GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC · Transducer, ultrasonic, diagnostic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page