FDA Device recall Z-1411-2019
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic table…
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic table… by Oakworks, citing table assembly error with incorrect actuators for the lateral and longitudinal table movements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1411-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-02 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Oakworks |
| Distribution | US |
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
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Identifiers
| code_info | Serial numbers:FLL745088, FLL745089, and FLL745090. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2019%22
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