GE MEDICAL SYSTEMS, ISRAEL LTD. Recall 93069
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
GE MEDICAL SYSTEMS, ISRAEL LTD. Recall 93069 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2652-2023 |
| Event ID | 93069 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR. |
| Quantity | 5986 devices |
| Recall 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. |
| Device Classification | 20231011 |
| Device Code Info | 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 |
| Center Classification Date | 20230929 |
| Recall Initiation Date | 20230906 |
| Recalling Firm | GE MEDICAL SYSTEMS, ISRAEL LTD. |
| Initial Notification | Letter |
| Similar To |