Date Initiated by Firm |
July 31, 2017 |
Date Posted |
February 23, 2018 |
Recall Status1 |
Terminated 3 on March 29, 2019 |
Recall Number |
Z-0703-2018 |
Recall Event ID |
79107 |
Product Classification |
Table, radiographic, tilting - Product Code IXR
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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
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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 |
Recalling Firm/ Manufacturer |
Oakworks Inc 923 E Wellspring Rd New Freedom PA 17349-8408
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For Additional Information Contact |
Deborah Berg 717-759-3118
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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.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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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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