Device product
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Z-0730-2024
Product summary
- Firm
- Oakworks Inc
- Event
- Event 93595
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-0730-2024
Official wording
Reason: Backrest platform stress fracture - the table is not operational in an inclined position
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
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Backrest platform stress fracture - the table is not operational in an inclined position