Events

Recall of Device Recall ISOLOC Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Civco Medical Instruments 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
    48463
  • Event Risk Class
    Class 2
  • Event Number
    Z-2137-2008
  • Event Initiated Date
    2008-06-18
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71476
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Reason
    A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
  • Action
    On 06/16/08 Civco Medical Solutions issued an Urgent-Medical Device Correction letter to all its customers by certified mail. This letter states the circumstances in which the device works incorrectly, a temporary work around and the information that the new software version 6.7 will address the issue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and returned acknowledging the receipt of the Device Correction Notification.

Device

Device Recall ISOLOC Software
  • Model / Serial
    Versions 6.6, 6.5 and 6.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
  • Product Description
    Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS || Is an EPID-based (electronic portal imaging device) version of localization software for determining the treatment machine position of radiotherapy targets.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Manufacturer Address
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA