Recall Z-2349-2021 ยท LGX Table, Examination, Medical, Powered
Oakworks Inc
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
| Date | Jun 29, 2021 |
| Status | Terminated |
| Reason | Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional |
| Root cause | Process control |
| Action | Oakworks issued Urgent Medical Device Recall letter dated 6/29/21. Letter states reason for recall , health risk and action to take: Actions to be taken are to immediately examine your inventory of OAKWORKS Inc., Ultrasound Vascular Table without Fowler (V1) and Ultrasound Vascular Table with Fowler (V2) to identify and locate all affected product(s). Do not distribute these affected product(s). Please quarantine the table(s). For tables that have been in use, they remain fully functional. Implement the field action as described below for the product listed in the Product and Distribution Inf |
| Quantity | 55 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.