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
    36187
  • Event Risk Class
    Class 2
  • Event Number
    Z-0478-2007
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48151
  • 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
    patient lift - Product Code FNG
  • Reason
    The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
  • Action
    Arjo sent an Urgent Device Field Correction Recall letter dated 8/31/06 to all affected end users to the attention of the Administrator/Risk Manager via FedEx on the same date. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to fatigue failure of the pivot bolt. The accounts were advised that an Arjo Field Service Technician would contact them within five business days to schedule a visit to the account to perform an upgrade of their Minstrel lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6140.

Device

Device Recall Minstrel Patient Lift
  • Model / Serial
    Model number HMB002-US, all serial numbers manufactured prior to June 2004. The production date can be determined by the serial number on the mast of the lift. Serial numbers start with MPLA or MPLAT, followed by the last two digits of the year and two digits for the month of production, i.e. MPLA0103 = March 2001.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US
  • Manufacturer
    Arjo, Inc.

Manufacturer

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