The Recall Desk
HighFDA (Devices)·Z-0730-2024·Announced 2024-01-24

Ultrasound Examination Table Recalled for Backrest Stress Fracture

Oakworks Inc is recalling 28 Ultrasound EA examination tables due to backrest platform stress fractures that prevent operation in an inclined position.

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: FDA Class II recall involving a structural defect that prevents normal device operation in inclined position. The stress fracture poses a potential risk of patient harm during use, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Oakworks Inc is recalling Ultrasound EA examination tables (Model V2) nationwide due to a structural defect affecting the backrest platform. The recall involves 28 units.

The backrest platform of affected tables can develop stress fractures, which make the table non-operational in an inclined position. This defect prevents the table from functioning during procedures that require inclined patient positioning.

Healthcare facilities that have received affected units should contact Oakworks Inc. This is an FDA Class II recall.

The recalled product

Product
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Manufacturer
Oakworks Inc
Category
Medical Device — Ultrasound examination table
Hazard
Affected units
28

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Oakworks Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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