Events

Recall of Device Recall OAKWORKS Medical Imaging Tables

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oakworks Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79107
  • Event Risk Class
    Class 2
  • Event Number
    Z-0703-2018
  • Event Initiated Date
    2017-07-31
  • Event Date Posted
    2018-02-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161387
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, radiographic, tilting - Product Code IXR
  • Reason
    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.
  • 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.

Device

Device Recall OAKWORKS Medical Imaging Tables
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution
  • Product Description
    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
  • Manufacturer
    Oakworks Inc

Manufacturer

Oakworks Inc
  • Manufacturer Address
    Oakworks Inc, 923 E Wellspring Rd, New Freedom PA 17349-8408
  • Manufacturer Parent Company (2017)
    Oakworks Inc.
  • Source
    USFDA