Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and Scale. A Non-AC-Powered Patient Lift

FDA device recall Z-0413-2009 · posted 2008-12-18 · Terminated

Recall details

Recalling firm

Arjo, Inc.

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FSA

Quantity affected

371 lifts, 10 scale kits

Distribution

Nationwide Distribution.

Date initiated

2008-10-30

Date posted

2008-12-18

Date terminated

2010-08-19

Location

Roselle, IL