Recall Z-2349-2021— Oakworks Inc
Class II · Terminated
Class II FDA medical device recall by Oakworks Inc, initiated 2021-06-29, terminated 2023-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219. Reason: Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional.
- Recalling firm
- Oakworks Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-29
- Terminated
- 2023-10-05
- Firm location
- New Freedom, PA, United States
Product description
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Reason for recall
Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional
Data sourced from openFDA. This site is unofficial and independent of the FDA.