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

Class 2 Device Recall Arjo Maxi 500 Patient Lift with 2Point Spreader Bar and Scale

  • 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
Arjo Maxi 500 Patient Lift with 2Point Spreader Bar and Scale
see related information
Date Posted December 18, 2008
Recall Status1 Terminated on August 19, 2010
Recall Number Z-0412-2009
Recall Event ID 50098
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with the optional scale kit 700.05505. The Maxi 500 is a mobile passive lifter, intended to be used for lifting and transferring of patients in hospitals, nursing homes of other health care facilities.
Code Information Model KM560101, serial numbers: KM5611219, KM5611322, KM5611076, KM5610713, KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551, KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006, KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013, KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020, KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027, KM5611084, KM5610813, KM5611290, KM5610667, and KM5611321; Scale model 700.05505, serial numbers: SO#5140275 and SO#5156094.
Recalling Firm/
Manufacturer
Arjo, Inc.
50 Gary Ave
Roselle, Illinois 60172-1605
For Additional Information Contact Ms. Traci Giovenco
800-323-1245 Ext. 6125
Manufacturer Reason
for Recall
If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Arjo, Inc. sent an Urgent Device Recall Customer Notification letter dated 10/29/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/30/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale if the spring pin is not replaced into the pivot bolt after performing maintenance on the lift. The accounts were advised to review the enclosed Urgent Field Safety Notice, note the affected model and serial numbers, and inspect their lifts for the presence of the spring pin in the pivot bolt. If the user finds that the spring pin is missing, they are instructed to immediately stop using the lift and contact their Arjo representative. The accounts were also instructed to remove previous versions of the Operating and Product Care instructions, and replace them with the current version 001.20815.EN Rev3 dated October 2008 provided with the letter, ensuring that the proper personnel are made aware of the changes outlined in the Field Safety Notice. Direct questions to the Arjo, Inc. Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax (888-594-2756) to Arjo, Inc. the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Field Safety Notice.
Quantity in Commerce 44 lifts, 2 scale kits
Distribution Nationwide Distribution.
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.
-
-