Events

Recall of Device Recall Xltek Protektor Stimulator (EPWorks software)

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

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
    70157
  • Event Risk Class
    Class 2
  • Event Number
    Z-1068-2015
  • Event Initiated Date
    2015-01-02
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132362
  • 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
    Stimulator, electrical, evoked response - Product Code GWF
  • Reason
    Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
  • Action
    Natus Medical Inc. DBA Excel-Tech Ltd (Xltek) issued medical device notification letters dated December 22, 2014 to their customers vial email and via courier service on January 2, 2015. Within the notice, customers are instructed are on to removal the previous installation and also on how to install the new program upgrade. Natus Medical Inc. has requested that the Previous Version Removed from Use Confirmation form be completed by each customer and returned. Customers who require assistance can contact Natus Technical service by calling 800-387-7516 or via email Oakville_Technical_Service@xltek.com or ots@natus.com.

Device

Device Recall Xltek Protektor Stimulator (EPWorks software)
  • Model / Serial
    EPWorks Software Versions prior to 6.0
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    EPWorks software used in the Xltek Protektor Stimulator || Product Usage: || Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Manufacturer Address
    Natus Medical Incorporated, 2568 Bristol Circle, Oakville Canada Ontario
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA