Events

Recall of Device Recall Clinitron At Home Air Fluidized Therapy Bed

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
    32236
  • Event Risk Class
    Class 2
  • Event Number
    Z-1555-05
  • Event Initiated Date
    2005-05-20
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39426
  • 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, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.
  • Action
    Customer letter was hand delivered to consignees by Hill-Rom Service Technicians 05/20/2005. The affected product will be corrected by replacement of the actuator with one from an unaffected lot.

Device

Device Recall Clinitron At Home Air Fluidized Therapy Bed
  • Model / Serial
    Serial numbers: CS102304, CS103257, CS103901, CS103902, CS103903, CS103904, CS103909, CS103911, CS103914, CS103915, CS103916, CS103917, CS103919, CS103921, CS103923, CS103924, CS103925, CS103928, CS103932, CS103933.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, FL, KY, LA, MA, NC, NY, TN, TX, VA
  • Product Description
    Clinitron At Home Air Fluidized Therapy Bed
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA