FDA recall Z-1411-2019

Oakworks Inc · Class II · device

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 for recall

Table assembly error with incorrect actuators for the lateral and longitudinal table movements

Distribution

US Nationwide distribution in the state of SC.

Key facts

Status
Terminated
Initiation date
2019-05-02
Report date
2019-05-29
Termination date
2019-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Freedom, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1411-2019