Events

Recall of Device Recall Clinitron At Home Air Fluidized Therapy Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Manufacturing, 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
    27190
  • Event Risk Class
    Class 2
  • Event Number
    Z-0057-04
  • Event Initiated Date
    2002-01-14
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29401
  • 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, Air Fluidized - Product Code INX
  • Reason
    Power cord overheating.
  • Action
    Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.

Device

Device Recall Clinitron At Home Air Fluidized Therapy Unit
  • Model / Serial
    Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hill Rom primarily leases these units to home care patients and some are sold nationwide.
  • Product Description
    Clinitron At Home¿ Air Fluidized Therapy Unit
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Road, Charleston SC 29405
  • Source
    USFDA