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 KCI USA, 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
    56849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0611-2011
  • Event Initiated Date
    2010-09-09
  • Event Date Posted
    2010-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94636
  • 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
    Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
  • Action
    KCI USA, Inc. sent an URGENT - Medical Device Safety Alert letter, dated September 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the cusotmer. Customers were instructed to have a practiced back-up plan, such as a plan for the manual proning of patients in the event that clinical circumstances dictate the need for more immediate prone therapy. For questions, customers in the US should call KCI's Technical Support Center at 1-800-275-4524, option 5. For customers outside the US they should contact their local sales representative. Customers should contact their accounts with affected product and advise them of the safety notice.

Device

RotoProne Therapy System
  • Model / Serial
    Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; and RRJK00002
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
  • Product Description
    RotoProne Therapy System, Model 209500, Device List Number E232632 || Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
  • Manufacturer
    KCI USA, Inc.

Manufacturer

KCI USA, Inc.
  • Manufacturer Address
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA