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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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 →Related recalls
Same manufacturer · Oakworks Inc
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