Oakworks Inc recalls OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are

Recalled May 29, 2019 · FDA recall Z-1411-2019 · Oakworks

Hazard

Table assembly error with incorrect actuators for the lateral and longitudinal table movements · FDA Class II

Units

3 units

Sold at

US Nationwide distribution in the state of SC.

Description

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 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.

Manufacturer(s)

Oakworks Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →