Class II — Oakworks Inc
| Recalling firm | Oakworks, INC. |
|---|---|
| Registered facility | OAKWORKS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Table assembly error with incorrect actuators for the lateral and longitudinal table movements |
| Product | 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 as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare … |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the state of SC. |
| Initiated | 2019-05-02 |
| Classified | 2019-05-23 |
| Terminated | 2019-07-08 |
| Recall number | Z-1411-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Oakworks Inc (Z-1411-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82852/
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