Events

Recall of Device Recall Arjo Ambulift Classic

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
    47885
  • Event Risk Class
    Class 2
  • Event Number
    Z-1651-2008
  • Event Initiated Date
    2008-05-05
  • Event Date Posted
    2008-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70439
  • 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
    Lift, Patient, Non-AC powered - Product Code FSA
  • Reason
    The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. the resultant fall could result in serious or fatal patient injuries.
  • Action
    Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.

Device

Device Recall Arjo Ambulift Classic
  • Model / Serial
    Models AKDB1890-04US and AKDB1895-04US, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
  • Product Description
    Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. || Model KDB1890-04US - Ambulift Classic with chair and leg rest. || Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale.
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA