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U.S. Department of Health and Human Services

Class 2 Device Recall Oakworks Ultrasound EA Table

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  Class 2 Device Recall Oakworks Ultrasound EA Table see related information
Date Initiated by Firm December 05, 2023
Date Posted January 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-0730-2024
Recall Event ID 93595
Product Classification Table, examination, medical, powered - Product Code LGX
Product Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Code Information (UDI): 00817463025521 S/N: VCF805597 VCF814488 VCF814750 VCF817222 VCF817223 VCF817720 VCF817721 VCF823450 VCF825629 VCF825630 VCF833350 VCF813968 VCF817520 VCF826533 VCF822117 VCF824501 VCF824502 VCF824503 VCF824504 VCF815120 VCF814849 VCF835728
Recalling Firm/
Manufacturer		 Oakworks Inc
923 E Wellspring Rd
New Freedom PA 17349-8408
For Additional Information Contact Stephen McKinley
717-235-6807
Manufacturer Reason
for Recall		 Backrest platform stress fracture - the table is not operational in an inclined position
FDA Determined
Cause 2		 Device Design
Action Oakworks Inc. issued "URGENT: MEDICAL DEVICE RECALL/CORRECTION" letter on 12/5/23 via Certified Mail/Email to Distributors and End Users. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory of OAKWORKS¿ Inc. Ultrasound EA Table with Echocardiography, or Electric Access Back Supports [left & right] to identify and locate all affected product(s). 2. For tables in use, they remain fully functional if the backrest platform stress fracture has not occurred. For tables that have the stress fracture or break, only use in a flat position until the backrest is replaced. 3. Implement the field action as described below for the product listed in the Product and Distribution Information Table. 4. 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. MAIL: Oakworks Inc. EMAIL: customerservice@oakworks.com Attn: Customer Service MDAN Response 923 East Wellspring Rd. New Freedom, PA 17349 Action by OAKWORKS¿ Inc.: Upon receipt of the Medical Device Advisory Notice Response Form(s), and to minimize the downtime of your OAKWORKS¿ Ultrasound EA table, we will setup a service visit to replace the backrest (if a stress fracture has occurred) or install a reinforcement plate (if a stress fracture has not occurred) on the table(s). The correction installation takes approximately 30 minutes. The replaced backrest will be disposed of by the service provider. Additional Information: If you have any questions or concerns, please contact our Customer Service Department at 800-558-8850 or 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
Quantity in Commerce 28 units
Distribution US Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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