Class II Recall

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound

Summary

The FDA issued a Class II for Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler ( by Oakworks Inc. Reason: Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-.

Details

Source

Device Recall

External ID

Z-2349-2021

Action Date

2021-09-01

Status

Terminated

Product Description

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

Lot/Code Info: 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;

Quantity Affected: 55 units

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

Distribution

Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2021-06-29

Company

Oakworks Inc

New Freedom, PA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Oakworks Inc has 7 FDA actions in our database, including 7 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oakworks Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Oakworks Inc have FDA actions?

Oakworks Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2349-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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