The Recall Desk
HighFDA (Devices)·Z-2349-2021·Announced 2021-09-01

Vascular Ultrasound Examination Table Recalled for Weld Failure

Oakworks vascular ultrasound examination tables (models USV1 and USV2) are recalled due to potential weld failure in the tilting mechanism bracket. A failed weld could prevent the table from tilting, affecting patient positioning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a structural weld failure on an examination table. No injuries or illnesses have been reported, but the weld failure represents a risk-of-harm scenario, as loss of tilting function could affect patient safety and proper examination positioning.

Plain-English summary

Oakworks Inc is recalling 55 units of Vascular Table models USV1 (without Fowler) and USV2 (with Fowler) due to a potential weld failure in a critical bracket. These tables are used in healthcare facilities for vascular ultrasound examinations.

The bracket that attaches the tabletop tilting actuator to the tabletop frame may fail at the weld. If this failure occurs, the table's tilting mechanism becomes non-functional, which prevents proper patient positioning during vascular ultrasound procedures.

The affected tables have been distributed nationwide. They are identified by Catalog Numbers 66783 (USV1) and 64219 (USV2), along with the specific serial numbers documented in the FDA recall notice.

Healthcare facilities with these tables should contact Oakworks Inc for inspection and repair guidance. The manufacturer has notified distributors of the recall.

The recalled product

Product
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Manufacturer
Oakworks Inc
Category
Medical Device — Ultrasound Examination Table
Hazard
  • weld-failure
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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