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Terminated

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

FDA Recall Z-0703-2018 · Posted 2018-02-23

Recalling FirmOakworks Inc
Recall StatusTerminated
Product CodeIXR
Date Initiated2017-07-31
Date Terminated2019-03-29
Product Quantity1,104

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

USA (nationwide) Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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