Oakworks Inc 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Oakworks issued a Medical Device Advisory Letter on 5/02/19 advising of the problem, and action to take: Immediately examine your inventory of OAKWORKS Inc., Multi-Movement Imaging Table: CFLU401 to identify and locate all affected product(s). 2) Do not distribute these affected product(s). Please quarantine the table(s). If further distribution of this product, contact your customer(s) with a copy of this letter and all applicable response forms. A service visit will replace the incorrect actuators on the table(s). Questions or concerns, please contact our Customer Service Department at 1-800-558-8850 or 1 717-235-6807