FDA recall Z-0728-2024

Oakworks Inc · Class II · device

Product

Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table

Reason for recall

Backrest platform stress fracture - the table is not operational in an inclined position

Distribution

US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2023-12-05
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Freedom, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2024