Oakworks Inc
Medical device manufacturer in New Freedom, PA.
0510(k) clearances
0PMA approvals
9recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0730-2024 Class II | Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section)…Backrest platform stress fracture - the table is not operational in an inclined position | 12/05/2023Open, Classified |
| Z-0729-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography…Backrest platform stress fracture - the table is not operational in an inclined position | 12/05/2023Open, Classified |
| Z-0728-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section)…Backrest platform stress fracture - the table is not operational in an inclined position | 12/05/2023Open, Classified |
| Z-0727-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound…Backrest platform stress fracture - the table is not operational in an inclined position | 12/05/2023Open, Classified |
| Z-1239-2022 Class II | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCSThe warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but… | 04/21/2022Terminated |
| Z-1238-2022 Class II | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19Product label was printed without the UDI number and warning label was printed with the incorrect weight… | 04/21/2022Terminated |
| Z-2349-2021 Class II | Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2).…Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld… | 06/29/2021Terminated |
| Z-1411-2019 Class II | OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product…Table assembly error with incorrect actuators for the lateral and longitudinal table movements | 05/02/2019Terminated |
| Z-0703-2018 Class II | Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging…The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401… | 07/31/2017Terminated |