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.
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 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
- Affected units
- 212
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
See all →- HighUltrasound examination tables recalled for backrest platform stress fractures
FDA (Devices) · 2024-01-24
- HighUltrasound Examination Table Recall Due to Backrest Platform Stress Fracture
FDA (Devices) · 2024-01-24
- HighUltrasound Examination Table Recalled for Backrest Stress Fracture
FDA (Devices) · 2024-01-24
- HighEmergency relief bed recalled for missing UDI and incorrect weight limit label
FDA (Devices) · 2022-06-15
- HighOakworks Emergency Field Bed Recalled for Incorrect Weight Capacity Label
FDA (Devices) · 2022-06-15
Similar recalls
- HighVascular Ultrasound Examination Table Recalled for Weld Failure
FDA (Devices) · 2021-09-01
- HighOakworks Lithotripsy Table Recalled for Incorrect Actuator Assembly Error
FDA (Devices) · 2019-05-29
- SeverePhilips Allura Centron patient table mattress defect poses fall risk
FDA (Devices) · 2025-02-26
- HighOakworks Medical Imaging Table Foot Controls Recalled for Lodging Hazard
FDA (Devices) · 2018-03-07
- HighEmergency relief bed recalled for missing UDI and incorrect weight limit label
FDA (Devices) · 2022-06-15
- ModerateSiemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction
FDA (Devices) · 2014-06-04