Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden

FDA device recall Z-2470-2008 · posted 2008-09-30 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from the t-bar attached to the lifter jib of the Maxi Move patient lift.

Action taken

Arjo sent the Field Safety Notice (FSN) dated 8/11/08 to all Maxi Move with Lock & Load system (Combi Hanger) customers on 9/8/08. The accounts were informed of the problem unintended dislocation of the hanger and possible detachment during patient transfer. The notice provided details, including serial number ranges, to identify the affected patient lifts affected, and instructed the accounts to re-train caregivers on how to ensure the hanger is properly attached to the T-bar before and during the initial phase of all lifting operations. Included with the FSN was a package containing a repair/replacement kit for the bushings in the T-bar with instructions, and updated copies of the Operating and Product Care instructions as well as a Preventative Maintenance Schedule manuals. The accounts were requested to complete and return to Arjo Inc. the enclosed customer response form indicating that they have received the notification package, that they installed the bushings kits in their affected Maxi Moves, or if they would like an Arjo Service Technician to perform the installation. Those locations needing a T-bar replacement will be contacted by an Arjo representative within 2 months to arrange a replacement of the T-bars.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

4,400 patient lifts

Distribution

Nationwide Distribution

Date initiated

2008-09-08

Date posted

2008-09-30

Date terminated

2011-01-07

Location

Roselle, IL