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.
FDA Recall Z-1411-2019 · Posted None
Recalling FirmOakworks Inc
Recall StatusTerminated
Product CodeIXR
Date Initiated2019-05-02
Date Terminated2019-07-08
Product Quantity3 units
Reason for Recall
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the state of SC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.