Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An U...
FDA Recall #Z-0730-2024 — Class II — December 5, 2023
Product Description
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
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
28 units
Distribution
US Nationwide Distribution
Code Information
(UDI): 00817463025521 S/N: VCF805597 VCF814488 VCF814750 VCF817222 VCF817223 VCF817720 VCF817721 VCF823450 VCF825629 VCF825630 VCF833350 VCF813968 VCF817520 VCF826533 VCF822117 VCF824501 VCF824502 VCF824503 VCF824504 VCF815120 VCF814849 VCF835728
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.