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U.S. Department of Health and Human Services

Class 2 Device Recall Maxilift

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 Class 2 Recall
Maxilift
see related information
Date Posted August 27, 2009
Recall Status1 Open
Recall Number Z-1945-2009
Recall Event ID 52126
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.
Code Information All models and all serial numbers of Maxilifts manufactured prior to January 1, 1997.
Recalling Firm/
Manufacturer
ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall
The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action ArjoHuntleigh sent a Field Safety Notice DCHU-UK/0209/001FSN to all affected end users via UPS Ground on 4/27/09. The notice informed the accounts of the potential for the roll pin to break due to a combination of severe corrosion and fatigue, leading to the detachment of the hanger bar from the jib of the lift. The accounts were advised to identify if they have any Arjo Maxilift patient lifters in their facility, identify which version of Arjo Maxilift hanger bar they have using the photographs in Figures 1,2 and 3 in the letter. Any lifters found with a hanger bar attachment as shown in Figure 1 must be immediately and permanently taken out of use, as the replacement hanger bar assembly is no longer available. Any lifters with a hanger bar attachment as shown in Figure 2 must be taken out of use until a correction has been performed by ArjoHuntleigh. Any lifters with a hanger bar attachment design as shown in Figure 3 are not affected and can continue being used. The accounts were provided with a product upgrade offer and a MaxiLift Preventative Maintenance Schedule. The accounts were requested to complete and fax, e-mail or mail the enclosed Customer Response Form to Arjo at 630-925-7974 or quality@arjousa.com, indicating the number of Maxilifts in each category that they have and that the products have been taken out of service for replacement or correction, listing the model numbers and serial numbers of their lifts. Questions were directed to the ArjoHuntleigh Customer Support or Quality Department at 1-800-323-1245.
Quantity in Commerce 8,015 lifts
Distribution Worldwide Distribution -- Countries of USA and Mexico.
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.
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