Events

Recall of HillRom 100 Low Bed (GPAC)

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
    72423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0274-2016
  • Event Initiated Date
    2015-10-07
  • Event Date Posted
    2015-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141077
  • 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
    Hill-rom is voluntarily recalling the hill-rom 100 low bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
  • Action
    Hill-Rom initiated Phase 1 of the recall on October 2, 2015, which included notices of the recall being issued to customers via certified mail, which included safety information on how to properly use the bed, and instructions to forward the information on if devices have been transferred. Phase 2 for the recall will include the distribution of caps for the edges of the bed to be placed on by the customers. Customers may contact Hill-Rom Technical Support at 800-445-3720.

Device

HillRom 100 Low Bed (GPAC)
  • Model / Serial
    Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.
  • Product Description
    Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA