Ultrasound examination tables recalled for backrest platform stress fractures
Oakworks recalled 20 Ultrasound EA and G3 examination tables due to backrest platform stress fractures that prevent proper operation in inclined positions. Affected units are identified by serial number.
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: This is an FDA Class II recall of medical equipment with a structural defect in a critical support component. No illnesses or injuries have been reported. Applied Score 3 (High) per rubric for risk-of-harm medical products where injury has not yet been reported.
Plain-English summary
Oakworks Inc is recalling 20 Ultrasound EA (Ergonomic Advantage) table versions and G3 Multi-Specialty Echocardiography tables with Electric Access Back Supports. The tables have a defective backrest platform that exhibits stress fractures.
The stress fracture in the backrest platform prevents the table from operating properly in an inclined position. This affects the table's ability to function correctly for ultrasound examination and diagnostic procedures.
The recall affects 20 units distributed nationwide in the United States. Affected serial numbers are: USM839457, USM839458, USM839459, USM839460, USM839461, USM818212, USM833897, USW813999, USM839614, USM839615, USM814871, USM833507, USM831797, USM823858, USM822620, USM824500, USM834529, USM788091, USM815794, USM832170.
If you own or operate one of these tables, avoid using it in the inclined position. Contact Oakworks Inc with your table's serial number for repair or replacement instructions.
The recalled product
- Product
- Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
- Manufacturer
- Oakworks Inc
- Affected units
- 20
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
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