Events

Recall of Device Recall INTIO Inc. ClearStartSVM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intio 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
    64435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2013
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2013-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116141
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    Intio inc. distributed a svm user's manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
  • Action
    INTIO sent a Recall Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. INTIO has corrected this version of the SVM User's Manual. An INTIO Inc. employee will contact the customers to replace the current manual with the correct one. Consignees were notified by letter that an INTIO Inc. employee will contact you within the next 30 days to replace the current manual with the correct one. The new SVM User's Manual will be provided to you once INTIO Inc. has retrieved the incorrect version of the SVM User's Manual. Customers with questions were instructed to email support@intio.us or call 303-396-1777. For questions regarding this recall call 303-396-9291.

Device

Device Recall INTIO Inc. ClearStartSVM
  • Model / Serial
    INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
  • Product Description
    INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
  • Manufacturer
    Intio Inc

Manufacturer

Intio Inc
  • Manufacturer Address
    Intio Inc, 325 Interlocken Pkwy, Broomfield CO 80021-3497
  • Manufacturer Parent Company (2017)
    Intio Inc.
  • Source
    USFDA