Z-0703-2018Class II

Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical...

Name: Z-0703-2018 Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical...
Creator: Oakworks Inc
Published: 2017-07-31
License: https://open.fda.gov/license/

Oakworks Inc / initiated 2017-07-31 / Terminated / root cause: design

FDA source

Oakworks Inc began a recall of Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400... on 2017-07-31. FDA classified it as Class II and gives the reason as "The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0703-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-31
Posted: 2018-02-23
Terminated: 2019-03-29
Recalling firm: Oakworks Inc
Product: Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400 Imaging Table OAKWORKS Medical CFPM 401 Imaging Table OAKWORKS Medical CFPMB 301 Bariatric Imaging Table OAKWORKS Medical CFUR 301 Urology Table OAKWORKS Medical CFUR 401 Urology Table OAKWORKS Medical CFLU 401 Lithotripsy/Urology Table
Product code: IXR Table, Radiographic, Tilting
Reason for recall: The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.
Root cause tag: design
FDA root cause: Device Design
Action: OAKWORKS, Inc. issued a MEDICAL DEVICE ADVISORY NOTICE dated 8/18/2017 to customers providing more information in regards to the Medical Device Advisory Notice sent on May 12, 2017. The advisory notice was initiated in response to reported issues with the foot control. OakWorks, Inc. customer service will place the order for the appropriate Foot Control Kit listed below based on what table is impacted and the date of manufacture. PN 2015-204 - Foot Control Kit - Standard Riser 2015-209 - Foot Control Kit - Thinner Riser 2015-210 - Foot Control Kit - Holder Only 2015-211 - Foot Control Kit - Riser Removal Customers with questions may contact 1-800-558-8850 or 1-717-235-6807.
Quantity in commerce: 1,104
Distribution: USA (nationwide) Distribution
Product codes and lots: MODEL #(s): "CFPM 300 "CFPM 301 "CFPM 400 "CFPM 401 "CFPMB 301 "CFUR 301 "CFUR 401 "CFLU 401 CATALOG #(s): "75208-T01 and 75209-T01 "75211-T01 and 75212-T01 "75204-T01 and 75205-T01 "75206-T01 and 75207-T01 "75213-T01 "75214-T01 "75215-T01 "75216-T01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0703-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

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)