Device product
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
Z-0729-2024
Product summary
- Firm
- Oakworks Inc
- Event
- Event 93595
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0729-2024
Official wording
Reason: Backrest platform stress fracture - the table is not operational in an inclined position
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
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Backrest platform stress fracture - the table is not operational in an inclined position