Events

Recall of MedilifterIII Plus and Summit Total 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
    47456
  • Event Risk Class
    Class 2
  • Event Number
    Z-1557-2008
  • Event Initiated Date
    2008-04-10
  • Event Date Posted
    2008-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69521
  • 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 FSA
  • Reason
    Scale could break and fall potentially causing injuries to someone who is on it. there is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. should a patient be in the lift at the time, the patient could fall and sustain injuries.
  • Action
    Arjo sent Urgent Device Recall Customer Notification letters dated 4/1/08 on the BHM Medical letterhead to the end user accounts who received the affected patient lifts with mast scales, advising them of the potential of fracture at the load cell assembly which might cause the scale to fall. Should a patient be in the lift at the time, the patient could fall, potentially sustaining injuries. The accounts were instructed to immediately stop using the patient lifts. A BHM representative will contact the accounts within 5 days to arrange for the correction of the lifts. The accounts will be given the option of returning the lifts for repair (with shipping costs covered by BHM), or purchasing a replacement lift at a significantly reduced price. Any questions or concerns were directed to the BHM Service Department at 1-819-868-0441 or service@bhm-medical.com.

Device

MedilifterIII Plus and Summit Total Lift
  • Model / Serial
    Medi-Lifter III Plus, serial numbers 76001/1013, 76003/1015, 76004/1014, 76005/1017, 76027/1019, 76028/1012, 76058/1024, 76128/1034, 76129/1025, 76132/1031, 76133/1039, 76162/1033, 76164/1035, 76221/1069, 76247/1065, 76251/1070, 77091/1079, 77092/1088, 77093/1083, 77126/1084, 77127/1085, 77295/1091, 77342/1096, 77343/1093, 77406/1099, 77407/1098, 77408/1092, 78035/1134, 78036/1132, 78037/1133, 78038/1128, 78039/1103, 78040/1130, 78041/1104;   Summit, serial numbers 4800157/1020, 4800166/1077, 4800173/1086
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
  • Product Description
    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); || Mast scale is Intended to be used for weighing patients while in the lifter. || Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5
  • Manufacturer
    Arjo, Inc.

Manufacturer

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