Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi...
FDA Recall #Z-0729-2024 — Class II — December 5, 2023
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
Recalling Firm
Oakworks Inc — New Freedom, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20 units
Distribution
US Nationwide Distribution
Code Information
(UDI): 00817463025422 S/N: USM839457 USM839458 USM839459 USM839460 USM839461 USM818212 USM833897 USW813999 USM839614 USM839615 USM814871 USM833507 USM831797 USM823858 USM822620 USM824500 USM834529 USM788091 USM815794 USM832170
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.