Recall Z-1411-2019— Oakworks Inc
Class II · Terminated
Class II FDA medical device recall by Oakworks Inc, initiated 2019-05-02, terminated 2019-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Table assembly error with incorrect actuators for the lateral and longitudinal table movements.
- Recalling firm
- Oakworks Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-02
- Terminated
- 2019-07-08
- Firm location
- New Freedom, PA, United States
Product description
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.
Reason for recall
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Data sourced from openFDA. This site is unofficial and independent of the FDA.