Z-0730-2024Class II

Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound...

Name: Z-0730-2024 Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound...
Creator: Oakworks Inc
Published: 2023-12-05
License: https://open.fda.gov/license/

Oakworks Inc / initiated 2023-12-05 / Open, Classified / root cause: design

FDA source

Oakworks Inc began a recall of Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table on 2023-12-05. FDA classified it as Class II and gives the reason as "Backrest platform stress fracture - the table is not operational in an inclined position". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0730-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-05
Posted: 2024-01-13
Recalling firm: Oakworks Inc
Product: Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Product code: LGX Table, Examination, Medical, Powered
Reason for recall: Backrest platform stress fracture - the table is not operational in an inclined position
Root cause tag: design
FDA root cause: 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: [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.
Quantity in commerce: 28 units
Distribution: US Nationwide Distribution
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0730-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0728-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0729-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0730-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

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)