Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Model

FDA device recall Z-0323-2009 · posted 2008-11-24 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.

Action taken

Arjo sent an Urgent Device Recall Customer Notification letter dated 10/20/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/20/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to shearing of the pivot bolt. The accounts were advised to review the enclosed Safety Advisory Notice, note the affected model and serial numbers, and avoid using the lift under load on a high friction floor like carpet or soft tile while using the hanger bar to move the lift. The accounts were advised that an Arjo Field Service Technician would contact them within two weeks to schedule a visit to the account to perform repairs on their Maxi 500 lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax back to Arjo 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 Urgent Device Correction.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FSA

Quantity affected

336 units

Distribution

Nationwide Distribution.

Date initiated

2008-10-20

Date posted

2008-11-24

Date terminated

2010-08-19

Location

Roselle, IL