Recall Z-0730-2024— Oakworks Inc
Class II · Ongoing
Class II FDA medical device recall by Oakworks Inc, initiated 2023-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table. Reason: Backrest platform stress fracture - the table is not operational in an inclined position.
- Recalling firm
- Oakworks Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-05
- Firm location
- New Freedom, PA, United States
Product description
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Reason for recall
Backrest platform stress fracture - the table is not operational in an inclined position
Data sourced from openFDA. This site is unofficial and independent of the FDA.