Ultrasound Examination Table Recall Due to Backrest Platform Stress Fracture
Oakworks Inc is recalling Ultrasound EA examination tables because the backrest platform can develop stress fractures, making the table inoperable in inclined positions. Approximately 104 units distributed nationwide are affected.
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 medical device has a structural defect (stress fracture in the backrest platform) that affects functionality and poses a potential risk to patient safety. Although no injuries have been reported, the structural failure of a medical examination table used in patient care qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Oakworks Inc is recalling Ultrasound EA (Ergonomic Advantage) examination tables used for echocardiography and general ultrasound procedures. The backrest platform is experiencing stress fractures that prevent the tables from operating properly when positioned at an incline.
The recall affects 104 units distributed throughout the United States. Affected tables can be identified by specific serial numbers beginning with USW, USM, and other designations listed in FDA recall notices.
Healthcare facilities using these tables should immediately discontinue use in inclined positions and contact Oakworks Inc for repair or replacement instructions. Facilities should verify whether their equipment is affected by checking their table serial numbers against the list provided in the official FDA recall notice.
The recalled product
- Product
- Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
- Manufacturer
- Oakworks Inc
- Affected units
- 104
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 (1)
- (UDI):
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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