FDA Enforcement
Class II
Ongoing
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Recall: Z-0730-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0730-2024
- Event ID
- 93595
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oakworks Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 24, 2024
- Initiation Date
- December 5, 2023
- Classification Date
- January 12, 2024
- Address
- 923 E Wellspring Rd, N/A, New Freedom, PA, 17349-8408, United States
Description
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Reason
Backrest platform stress fracture - the table is not operational in an inclined position
Code Info
(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
Distribution
US Nationwide Distribution
Quantity
28 units