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

Recall date

May 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1411-2019

FDA classification

Class II

Brand / firm

Oakworks Inc

Sold / distributed

US Nationwide distribution in the state of SC.

Why it was recalled

Table assembly error with incorrect actuators for the lateral and longitudinal table movements

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.