Events

Recall of HillRom Affinity Three Birthing Bed.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, 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
    36142
  • Event Risk Class
    Class 2
  • Event Number
    Z-1503-06
  • Event Initiated Date
    2006-08-18
  • Event Date Posted
    2006-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48066
  • 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
    birthing bed - Product Code KNC
  • Reason
    The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.
  • Action
    Customers were notified via letter dated 8/18/06 and instructed to either correct the problem themselves with the instructions provided or to contact the firm requesting a visit from the recalling firm to correct their beds.

Device

HillRom Affinity Three Birthing Bed.
  • Model / Serial
    All units distributed after October 2000 and equipped with the 12VAC accessory outlet option.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, France, French Polynesia, Germany, Guam, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Sait Kitts and Nevis, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands and Venezuela.
  • Product Description
    Hill-Rom Affinity Three Birthing Bed, Model P3700.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, Batesville IN 47006
  • Source
    USFDA