The Recall Desk
HighFDA (Devices)·Z-0727-2024·Announced 2024-01-24

Ultrasound examination table recalled due to backrest platform stress fracture

Oakworks Inc is recalling 212 Ultrasound EA G2 examination tables nationwide due to stress fractures in the backrest platform that make the equipment non-operational 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 without reported hospitalizations, injuries, or deaths. The hazard is a structural defect (backrest stress fracture) creating potential risk of equipment failure during use, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Oakworks Inc is recalling 212 Ultrasound EA (Ergonomic Advantage) G2 examination tables distributed nationwide in the United States. These tables are affected by stress fractures in the backrest platform.

Due to the structural defect, the tables are not operational in an inclined position. This defect prevents the equipment from functioning properly for ultrasound procedures requiring inclined positioning. The affected units can be identified by UDI 00817463025323 and their specific serial numbers as listed in the recall notice.

The FDA has classified this as a Class II recall.

The recalled product

Product
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Manufacturer
Oakworks Inc
Category
Medical Device — Medical examination equipment
Hazard
  • stress-fracture
  • equipment-failure

Distribution

Distributed nationwide across the United States.

Related recalls

Same category