• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MedilifterIII Plus and Summit Total Lift

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
MedilifterIII Plus and Summit Total Lift
see related information
Date Posted July 30, 2008
Recall Status1 Terminated on November 18, 2009
Recall Number Z-1557-2008
Recall Event ID 47456
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product 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
Code Information 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
Recalling Firm/
Manufacturer
Arjo, Inc.
50 Gary Ave Ste A
Roselle, Illinois 60172-1684
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Traci Giovenco
630-307-2756
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 37 lifts
Distribution Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-