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
This recall has been terminated (originally issued February 23, 2018).
- Company
- Oakworks Inc
- Recall Initiated
- July 31, 2017
- Posted
- February 23, 2018
- Terminated
- March 29, 2019
- Recall Number
- Z-0703-2018
- Quantity
- 1,104
- Firm Location
- New Freedom, PA
- Official Source
- View on FDA website ↗
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.
Distribution
USA (nationwide) Distribution
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.