FDA Enforcement
Class II
Ongoing
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
Recall: Z-0729-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0729-2024
- 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 versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
Reason
Backrest platform stress fracture - the table is not operational in an inclined position
Code Info
(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
US Nationwide Distribution
Quantity
20 units