Events

Recall of Device Recall Insight

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sandhill Scientific, 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
    53340
  • Event Risk Class
    Class 2
  • Event Number
    Z-1487-2012
  • Event Initiated Date
    2009-02-23
  • Event Date Posted
    2012-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86301
  • 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, gastrointestinal motility (electrical) - Product Code FFX
  • Reason
    Software error may produce incorrect esophageal contraction readings.
  • Action
    Sandhill Scientific sent a Urgent Product Recall letter dated February 23, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed All Suite revision H, BioVIEW Analysis Software rev 5.5.1 are affected. Replacement of the Suite revision H, BioVIEW Analysis Software rev 5.5.1, will be provided at no cost to you. Sandhill Scientific will pay for shipping/handling charges associated with replacement of this software. We anticipate that by the first week of March, we will be able to provide you with the Software that resolves this problem. For further questions please call toll free 800-468-4556.

Device

Device Recall Insight
  • Model / Serial
    S98-1925-2H; S98-1925-4H All lots and shipments of the software.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, FL, IA, IL, MA, MD, MI, MN, NC, ND, NE, NM, NY, OH, OR, PA, SC, SD, TX, UT, VA and WA and the countries of Belgium, Canada, Malaysia, Mexico, New Zealand, South-Korea, Switzerland and United Kingdom.
  • Product Description
    Insight rev H software. || The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.
  • Manufacturer
    Sandhill Scientific, Inc

Manufacturer

Sandhill Scientific, Inc
  • Manufacturer Address
    Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
  • Source
    USFDA