Reported May 29, 2019 · Terminated

OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables…

Oakworks Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Oakworks Inc · 923 E Wellspring Rd · New Freedom, PA · 17349-8408

Is this the product you have?

  • OAKWORKS Inc
  • Lithotripsy/Urology TableCFLU401
  • Catalog Number75216-T01 -
  • Product UsageOakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient
Lot codes and dates
  • Serial numbers
    • FLL745088
    • FLL745089
    • and FLL745090
Amount recalled
3 units

Where it was sold

  • Nationwide
  • SC

Why it was recalled

Table assembly error with incorrect actuators for the lateral and longitudinal table movements

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2019 · Data as of Sep 19, 5:39 PM UTC

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