Recall of Device Recall MPI Rapid Response HUT Table, Model RRHUT 1017

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Positioning 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
    61348
  • Event Risk Class
    Class 2
  • Event Number
    Z-1211-2012
  • Event Initiated Date
    2012-03-05
  • Event Date Posted
    2012-03-15
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-07-11
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Table, examination, medical, powered - Product Code LGX
  • Reason
    The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "off" position prior to connecting the unit to electric power.
  • Action
    Medical Positioning Inc. sent a "RAPID RESPONSE HUT TABLE LABELING CORRECTION NOTIFICATION" letter dated March 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included an Owner's Manual insert page which clearly states the warning and how to avoid the electric shock hazard and a warning tag to attach to the product's power cord near the plug end using the provided wire tie. Contact the firm at 816-595-2356 for questions regarding this notice.

Device

  • Model / Serial
    Serial numbers 802421, 802780, 802781 802783, and 802784
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of IN, KS, WI, NY, IL, NC, OH, and MS and the country of Thailand.
  • Product Description
    MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc., Kansas City, MO. || Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Medical Positioning Inc, 1717 Washington St, Kansas City MO 64108-1121
  • Manufacturer Parent Company (2017)
  • Source
    USFDA