FDA recall Z-2349-2021

Oakworks Inc · Class II · device

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 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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2021-06-29
Report date
2021-09-01
Termination date
2023-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Freedom, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2349-2021