Recall Z-0729-2024— 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 versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}. 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 versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
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.