Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional

FDA device recall Z-1945-2009 · posted 2009-08-27 · Terminated

Recall details

Recalling firm

ArjoHuntleigh

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

FSA

Quantity affected

8,015 lifts

Distribution

Worldwide Distribution -- Countries of USA and Mexico.

Date initiated

2009-04-27

Date posted

2009-08-27

Date terminated

2011-02-25

Location

Addison, IL