Z-1411-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- July 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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
Distribution Pattern
US Nationwide distribution in the state of SC.
Code Information
Serial numbers:FLL745088, FLL745089, and FLL745090.