New Freedom, PA, United States
Oakworks Inc recalls
5 recalls recorded since 2018, most recently on 5 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 December 2023
- Reason
- Backrest platform stress fracture - the table is not operational in an inclined position
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0729-2024, Z-0728-2024, Z-0730-2024, Z-0727-2024
- Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
- Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
- Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
- Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Terminated Class II Medical devices
- Recall started
- 21 April 2022
- Terminated
- 19 September 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of MA, NJ, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1238-2022, Z-1239-2022
- PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
- Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
Terminated Class II Medical devices
- Recall started
- 29 June 2021
- Terminated
- 5 October 2023
- Reason
- 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
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 2 May 2019
- Terminated
- 8 July 2019
- Reason
- Table assembly error with incorrect actuators for the lateral and longitudinal table movements
- Distribution
- US Nationwide distribution in the state of SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 31 July 2017
- Terminated
- 29 March 2019
- Reason
- 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.
- Distribution
- USA (nationwide) Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.