Class 2 Device Recall Oakworks Imaging Tables

• Date Initiated by Firm: May 02, 2019
• Create Date: May 23, 2019
• Recall Status: Terminated on July 08, 2019
• Recall Number: Z-1411-2019
• Recall Event ID: 82852
• Product Classification: Table, radiographic, tilting - Product Code IXR
• 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.
• Code Information: Serial numbers:FLL745088, FLL745089, and FLL745090.
• Recalling Firm/ Manufacturer: Oakworks Inc; 923 E Wellspring Rd; New Freedom PA 17349-8408
• For Additional Information Contact: SAME; 717-235-6807
• Manufacturer Reason for Recall: Table assembly error with incorrect actuators for the lateral and longitudinal table movements
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 3 units
• Distribution: US Nationwide distribution in the state of SC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.