Recall Z-0727-2024 ยท LGX Table, Examination, Medical, Powered
Oakworks Inc
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
| Date | Jan 13, 2024 (initiated Dec 5, 2023) |
| Status | Open, Classified |
| Reason | Backrest platform stress fracture - the table is not operational in an inclined position |
| Root cause | Device Design |
| Action | Oakworks Inc. issued "URGENT: MEDICAL DEVICE RECALL/CORRECTION" letter on 12/5/23 via Certified Mail/Email to Distributors and End Users. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory of OAKWORKS Inc. Ultrasound EA Table with Echocardiography, or Electric Access Back Supports [left & right] to identify and locate all affected product(s). 2. For tables in use, they remain fully functional if the backrest platform stress fracture has not occurred. For tables that have the stress fracture or break, only use in a flat position until the b |
| Quantity | 212 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.