# FDA recall Z-1411-2019

> **Oakworks Inc** · Class II · device recall initiated 2019-05-02.

## 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

## Distribution

US Nationwide distribution in the state of SC.

## Key facts

- **Recall number:** Z-1411-2019
- **Recalling firm:** Oakworks Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-02
- **Report date:** 2019-05-29
- **Termination date:** 2019-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Freedom, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1411-2019

## Citation

> AI Analytics. FDA recall Z-1411-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1411-2019. Source: US FDA. Licensed CC0.

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