Z-2349-2021Class II

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2)

Name: Z-2349-2021 Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2)
Creator: Oakworks Inc
Published: 2021-06-29
License: https://open.fda.gov/license/

Oakworks Inc / initiated 2021-06-29 / Terminated / root cause: manufacturing process

FDA source

Oakworks Inc began a recall of Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number... on 2021-06-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2349-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-29
Posted: 2021-08-25
Terminated: 2023-10-05
Recalling firm: Oakworks Inc
Product: Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Product code: LGX Table, Examination, Medical, Powered
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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
Quantity in commerce: 55 units
Distribution: Nationwide
Product codes and lots: Serial Number/Part Number VCF766794 USGNV22723723MTTZZCE2S; VCF767303 USGNV23023723MTTZZ2S; VCF771999 USGNV23023723MTTZZ2S; VCF774252 USGNV23023723MTTZZ2S; VCF776073 USGNV23023723MTTZZ2S; VCF776198 USGNV23023723MTTZZ2S; VCF778246 USGNV23023723MTTZZ2S; VCF778247 USGNV23023723MTTZZ2S; VCF779362 USGNV23023723MTTZZ2S; VCF780260 USGNV23023723MTTZZ2S; VCS781126 USGNV13023723MTTZZ2S; VCF783652 USGNV22723723MTTZZF82S; VCF783969 USGNV23023723MTTZZF82S; VCF785961 USGNV22723723MTTZZCE2S; VCS766698 USGNV12723723MTTZZF62S; VCF768278 USGNV23023723MTTZZCEDRMC2S; VCF770016 USGNV23023723MTTZZ2S; VCF770017 USGNV23023723MTTZZ2S; VCF770571 USGNV23023723MTTZZCE2S; VCF771782 USGNV23023723MTTZZF8MC2S; VCF776974 USGNV22723723MTTZZ2S; VCF778602 USGNV23023723MTTZZ2S; VCF779609 USGNV23023723MTTZZF8CE2S; VCF781198 USGNV23023723MTTZZ2S; VCF784255 USGNV23023723MTTZZCE2S; VCF785376 USGNV23023723MTTZZ2S; VCF785650 USGNV23023723MTTZZF8MC2S; VCF786137 USGNV23023723MTTZZ2S; VCF786173 USGNV23023723MTTZZCE2S; VCF771553 USGNV23023723MTTZZCEMC2S; VCF771554 USGNV23023723MTTZZCEMC2S; VCF785065 USGNV22723723MTTZZF8CEDRDL2S; VCF771992 USGNV23023723MTTZZF8DRDL2S; VCF771993 USGNV23023723MTTZZF8DRDL2S; VCF782916 USGNV23023723MTTZZF8DRDL2S; VCF772035 USGNV22723723MTTZZ2S; VCF777288 USGNV22723723MTTZZ2S; VCF779024 USGNV22723723MTTZZ2S; VCF779025 USGNV22723723MTTZZ2S; VCF779026 USGNV22723723MTTZZ2S; VCF780977 USGNV22723723MTTZZ2S; VCF785219 USGNV22723723MTTZZ2S; VCF771311 USGNV23023723MTTZZ2S; VCF785744 USGNV22723723MTTZZCE2S; VCS772698 USGNV12723723MTTZZ2S; VCF771236 USGNV22723723MTTZZF8CE2S; VCF775658 USGNV23023723MTTZZ2S; VCF776370 USGNV23023723MTTZZ2S; VCF792903 USGNV23023723MTTZZMC2S; VCF773748 USGNV23023723MTTZZF8MC2S; VCF773748 USGNV23023723MTTZZCE2S; VCF779429 USGNV23023723MTTZZF8CE2S; VCF779921 USGNV23023723MTTZZF82S; VCF783233 USGNV23023723MTTZZ2S; VCF786329 USGNV22723723MTTZZ2S;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2349-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2349-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25

Product code LGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)