Events

Recall of Device Recall RotoRest Delta Kinetic 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
    62805
  • Event Risk Class
    Class 2
  • Event Number
    Z-0409-2013
  • Event Initiated Date
    2012-06-27
  • Event Date Posted
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111749
  • 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, flotation therapy, powered - Product Code IOQ
  • Reason
    The firm is initiating a voluntary medical device correction for the rotorest delta therapy system head pack. kci has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. in a few instances, the patient received injuries ranging from stage iii to stage iv pressure ulcers.
  • Action
    KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

Device

Device Recall RotoRest Delta Kinetic Therapy System
  • Model / Serial
    Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, CA, CO, OK and GA.
  • Product Description
    RotoRest Delta Kinetic Therapy System || INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
  • Manufacturer
    KCI USA, Inc.

Manufacturer

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