FDA-Device2021-09-01Class II

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

Oakworks Inc
Hazard

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

Sold states
Nationwide
Affected count
55 units
Manufactured in
923 E Wellspring Rd, N/A, New Freedom, PA, United States
Products
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

Official notice

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

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