OAKWORKS Inc — Class II medical device recall Z-1411-2019
Terminated recall by Oakworks Inc, reported 2019-05-29, distributed nationwide. Table assembly error with incorrect actuators for the lateral and longitudinal table movements
| Recall number | Z-1411-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oakworks Inc, New Freedom, PA, United States |
| Recall initiated | 2019-05-02 |
| Classified | 2019-05-23 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2019-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Serial numbers | FLL745088, FLL745089, FLL745090 |
| Model numbers | 75216-T01 |
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 professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.
Reason for recall
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1411-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.