Events

Recall of Rotoprone Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArjoHuntleigh 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
    67248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0926-2014
  • Event Initiated Date
    2013-09-11
  • Event Date Posted
    2014-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125084
  • 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
    Bed, patient rotation, powered - Product Code IKZ
  • Reason
    The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient.
  • Action
    ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.

Device

Rotoprone Therapy System
  • Model / Serial
    Model #209500
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and Middle East
  • Product Description
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. || Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
  • Manufacturer
    ArjoHuntleigh Inc.

Manufacturer

ArjoHuntleigh Inc.
  • Manufacturer Address
    ArjoHuntleigh Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA