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U.S. Department of Health and Human Services

Class 2 Device Recall OAKWORKS Medical Imaging Tables

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 Class 2 Device Recall OAKWORKS Medical Imaging Tablessee related information
Date Initiated by FirmJuly 31, 2017
Date PostedFebruary 23, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall NumberZ-0703-2018
Recall Event ID 79107
Product Classification Table, radiographic, tilting - Product Code IXR
ProductFoot 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
Code Information 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 
FEI Number 1000121370
Recalling Firm/
Manufacturer		 Oakworks Inc
923 E Wellspring Rd
New Freedom PA 17349-8408
For Additional Information ContactDeborah Berg
717-759-3118
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOAKWORKS, 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 Commerce1,104
DistributionUSA (nationwide) Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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