Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An U...

FDA Recall #Z-0730-2024 — Class II — December 5, 2023

Recall #Z-0730-2024 Date: December 5, 2023 Classification: Class II Status: Ongoing

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.

Back to All Device Recalls