Recall Z-1411-2019 ยท IXR Table, Radiographic, Tilting
Oakworks Inc
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | Table assembly error with incorrect actuators for the lateral and longitudinal table movements |
| Root cause | Nonconforming Material/Component |
| Action | Oakworks issued a Medical Device Advisory Letter on 5/02/19 advising of the problem, and action to take: Immediately examine your inventory of OAKWORKS Inc., Multi-Movement Imaging Table: CFLU401 to identify and locate all affected product(s). 2) Do not distribute these affected product(s). Please quarantine the table(s). If further distribution of this product, contact your customer(s) with a copy of this letter and all applicable response forms. A service visit will replace the incorrect actuators on the table(s). Questions or concerns, please contact our Customer Service Department at 1-8 |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the state of SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.