Oakworks Inc
New Freedom, PA, US
OAKWORKS, INC. appears in FDA device records in New Freedom, PA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2529571 | 1000121370 | OAKWORKS, INC. | 923 E Wellspring Rd, NEW FREEDOM, PA 17349 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0730-2024 | Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Open, Classified | |
| Z-0729-2024 | Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right} | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Open, Classified | |
| Z-0728-2024 | Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Open, Classified | |
| Z-0727-2024 | Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Open, Classified | |
| Z-1239-2022 | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs. | Class II | Terminated | |
| Z-1238-2022 | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 | Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs. | Class II | Terminated | |
| Z-2349-2021 | Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219 | Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional | Class II | Terminated | |
| Z-1411-2019 | OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient. | Table assembly error with incorrect actuators for the lateral and longitudinal table movements | Class II | Terminated | |
| Z-0703-2018 | Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400 Imaging Table OAKWORKS Medical CFPM 401 Imaging Table OAKWORKS Medical CFPMB 301 Bariatric Imaging Table OAKWORKS Medical CFUR 301 Urology Table OAKWORKS Medical CFUR 401 Urology Table OAKWORKS Medical CFLU 401 Lithotripsy/Urology Table | The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain