Events

Recall of Device Recall Ergolift and Ergolift2 Floor LIfts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo, 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
    50756
  • Event Risk Class
    Class 2
  • Event Number
    Z-0933-2009
  • Event Initiated Date
    2008-12-08
  • Event Date Posted
    2009-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76981
  • 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
    Non-Ac-Powered Patient Lift - Product Code FSA
  • Reason
    The manufacturer, bhm medical, has received reports of structural failure of the mast during use.
  • Action
    Arjo sent the Urgent Device Recall letter dated 12/22/08 and Field Safety Notice (FSN) dated 12/8/08 to their Ergolift customers on 12/22/08. The accounts were informed of the potential structural failure of the mast on the BHM Medical Ergolift. The letter instructed the accounts to discontinue use of the lifts immediately. Those lifts with serial numbers ERLI-0001 and ERLI-0899 will be taken out of service permanently, and will be replaced with a new device at a significant discount. Those lifts with serial numbers ERLI-0900 and ERLI-1717 will be corrected by a reinforcement kit installed by a qualified technician. The accounts were requested to complete and return to Arjo Inc. within 10 days the enclosed customer response form indicating that they have received the notification, indicating the serial numbers on hand needing correction, and whether they need any replacement lifts. The accounts will be contacted by an Arjo technician within weeks to arrange for the correction of the lifts and/or an Arjo representative for the replacement lifts.

Device

Device Recall Ergolift and Ergolift2 Floor LIfts
  • Model / Serial
    serial numbers ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 || The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave, Roselle IL 60172-1605
  • Source
    USFDA