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Ultrasound EA (Ergonomic Advantage) table versions recallZ-0729-2024 · Oakworks Inc · initiated Dec 5, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Oakworks Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Backrest platform stress fracture - the table is not operational in an inclined position

FDA root cause category: Device Design

What the company is doing

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: [email protected] 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.

Recall details

Recall number
Z-0729-2024
Status
Open, Classified
Initiated by the company
Dec 5, 2023
Posted by the FDA
Jan 13, 2024
Recalling firm
Oakworks Inc
Quantity
20 units
Product code
LGX
Distribution
US Nationwide Distribution

Product description

Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}

Code information (models, lots, serial numbers)

(UDI): 00817463025422 S/N: USM839457 USM839458 USM839459 USM839460 USM839461 USM818212 USM833897 USW813999 USM839614 USM839615 USM814871 USM833507 USM831797 USM823858 USM822620 USM824500 USM834529 USM788091 USM815794 USM832170

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93595).

Sources and updates

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