Events

Recall of Device Recall ISOLOC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Northwest Medical Physics Equipment 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
    38366
  • Event Risk Class
    Class 2
  • Event Number
    Z-1155-2007
  • Event Initiated Date
    2004-11-30
  • Event Date Posted
    2007-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53491
  • 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
    Radiotherapy localization software - Product Code IYE
  • Reason
    When isoloc version 4.2 unit is set to centimeter and the user clicks the reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
  • Action
    Software to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.

Device

Device Recall ISOLOC
  • Model / Serial
    ISOLOC Software Version 4.2, Part Number NT-NW-425-520.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Korea, Spain, and UK.
  • Product Description
    ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
  • Manufacturer
    Northwest Medical Physics Equipment Inc

Manufacturer

Northwest Medical Physics Equipment Inc
  • Manufacturer Address
    Northwest Medical Physics Equipment Inc, 1910 120th Pl SE, Suite 101, Everett WA 98208
  • Source
    USFDA