Recall of Device Recall Rapid Response HUT Table

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
    58035
  • Event Risk Class
    Class 2
  • Event Number
    Z-1974-2011
  • Event Initiated Date
    2010-02-01
  • Event Date Posted
    2011-04-13
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-06-15
  • 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
    Tilting Radiologic Table - Product Code IXR
  • Reason
    The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
  • Action
    An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or jhurtig@medicalpositioning.com to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructions were sent to each consignee. The instructions consisted of (1) Rapid Response HUT Motor Replacement Instructions; (2) Control Box Replacement Instructions; and (3) ILD External Power Supply Removal Instructions.

Device

  • Model / Serial
    599236, 599457, 599764, 599780,599802, 599845, 599898, 600012, 600047, 600249, 600290, 600304, and 600809 located on the side of the table.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico, and Canada.
  • Product Description
    Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. || Used in clinical and hospital settings by trained radiologists.
  • Manufacturer

Manufacturer

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