Events

Recall of Device Recall Minstrel Patient Lift

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
    28866
  • Event Risk Class
    Class 2
  • Event Number
    Z-0883-04
  • Event Initiated Date
    2003-01-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32647
  • 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 tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
  • Action
    All affected end users were given a copy of the Customer Advisory Notice dated 1/30/03, during the Arjo salesmen visits to inspect the Minstrel lifts for the presence of the tension pin in the pivot bolt of the lift. The advisory informed the user of the incident where the spreader bar detached from the scale unit. The end user was requested to read the advisory and sign the bottom portion of it certifying that they read the advisory and that the Arjo salesman inspected their units for the presence of the tension pin, retaining a copy of the signed advisory notice and the inspeciton record.

Device

Device Recall Minstrel Patient Lift
  • Model / Serial
    model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLA0203A0464
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, South Carolina, Minnesota and Colorado
  • Product Description
    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
  • Manufacturer
    Arjo, Inc.

Manufacturer

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