PlainRecalls
FDA Devices Moderate Class II Terminated

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 Tabl

Reported: May 29, 2019 Initiated: May 2, 2019 #Z-1411-2019

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

Details

Recalling Firm
Oakworks Inc
Units Affected
3 units
Distribution
US Nationwide distribution in the state of SC.
Location
New Freedom, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Oakworks Inc. Units affected: 3 units.
Why was this product recalled? ▼
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1411-2019.

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