Z-1411-2019Class II

OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 -

Name: Z-1411-2019 OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 -
Creator: Oakworks Inc
Published: 2019-05-02
License: https://open.fda.gov/license/

Oakworks Inc / initiated 2019-05-02 / Terminated / root cause: manufacturing process

FDA source

Oakworks Inc began a recall of OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use... on 2019-05-02. FDA classified it as Class II and gives the reason as "Table assembly error with incorrect actuators for the lateral and longitudinal table movements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1411-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-05-23
Terminated: 2019-07-08
Recalling firm: Oakworks Inc
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.
Product code: IXR Table, Radiographic, Tilting
Reason for recall: Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Oakworks issued a Medical Device Advisory Letter on 5/02/19 advising of the problem, and action to take: Immediately examine your inventory of OAKWORKS Inc., Multi-Movement Imaging Table: CFLU401 to identify and locate all affected product(s). 2) Do not distribute these affected product(s). Please quarantine the table(s). If further distribution of this product, contact your customer(s) with a copy of this letter and all applicable response forms. A service visit will replace the incorrect actuators on the table(s). Questions or concerns, please contact our Customer Service Department at 1-800-558-8850 or 1 717-235-6807
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the state of SC.
Product codes and lots: Serial numbers:FLL745088, FLL745089, and FLL745090.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1411-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1411-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-23

Product code IXR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)