Class 2 Device Recall Venue Go Standard Carts used with Venue Go

• Date Initiated by Firm: September 06, 2023
• Date Posted: September 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2652-2023
• Recall Event ID: 93069
• 510(K)Number: K183362 K202233 K220800
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• 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
• 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
• Recalling Firm/ Manufacturer: GE MEDICAL SYSTEMS, ISRAEL LTD.; Nativ Haa??or Street no. 1; HAIFA Israel
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = GE Medical Systems Ultrasound and Primary Care Diagnostics; 510(K)s with Product Code = IYN and Original Applicant = GE Medical Systems Ultrasound and Primary Care Diagnostics,