Vascular Table (Oakworks) – Weld Failure Risk (2021)

Check Your Product

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

Reason for Recall

As stated by FDA

Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional

Recommended Action

Per FDA guidance

Oakworks issued Urgent Medical Device Recall letter dated 6/29/21. Letter states reason for recall , health risk and action to take: Actions to be taken are to immediately examine your inventory of OAKWORKS Inc., Ultrasound Vascular Table without Fowler (V1) and Ultrasound Vascular Table with Fowler (V2) to identify and locate all affected product(s). Do not distribute these affected product(s). Please quarantine the table(s). For tables that have been in use, they remain fully functional. Implement the field action as described below for the product listed in the Product and Distribution Information. Enclosed is a Medical Device Advisory Notice Response Form for each product we believe you have. Please complete this form in its entirety and return to OAKWORKS Inc., within 48 hours of receipt of this advisory notice via any of the options listed below. If you have further distributed this product, immediately contact your customer(s) with a copy of this letter and all applicable response forms. Then, provide OAKWORKS Inc. with the contact information for your customer(s) to whom this product(s) has been distributed by using the Medical Device Advisory Notice Response Form within 48 hours. Please note that you are required by the United States Food and Drug Administration to contact your customer(s) who are currently in possession of the product and inform them of this Medical Device Advisory Notice. MAIL: Oakworks Inc. EMAIL: qualitycare@oakworks.com Attn: Quality Care MDAN Response FAX: (717) 235-6798 923 East Wellspring Rd. New Freedom, PA 17349 What OAKWORKS Inc. will do next: Upon receipt of the Medical Device Advisory Notice Response Form(s), and to minimize the downtime of your OAKWORKS Ultrasound Vascular Table (V1) or (V2), we will setup a service visit to replace the Tilt Actuator Bracket on the table(s). The correction installation takes approximately 30 minutes. The replaced bracket will be disposed of by the service provider. If you have any quest