Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers

FDA device recall Z-1046-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

There has been an increased number of tipping incidents and subsequent patient injuries.

Action taken

Safety Advice Notice letters dated 6/8/04 were sent by certified mail to the end users, informing them of the possibility of tipping if the Alenti catches on other equipment; if the resident is not positioned correctly on the chair; if the Alenti is used with an inappropriate resident; if the resident is left unattended, particularly when the Alenti is in an elevated position; and if the safety belt is not used as a positioning belt. The end users were provided with a laminated hang tag to place on the lift with the listed safety aspects and warnings, a copy of the revised Alenti Operating and Product Care Instructions dated April 2004, and an Alenti safety belt for each of their lifts. The users were requested to complete enclosed customer response form indicating that they received and understood the safety advice notice, that they received the revised manual and destroyed all previous copies of the manual, that they received a safety belt for each lift, and that they made the patient lift operators aware of the safety advice notice and that they understood its contents. Any questions were directed to the Quality Assurance Department, at 1-800-323-1245, ext. 6103. Revised hang tags including instructions to check the castors on the lift to assure that they are secured and functioning properly, as well as providing the operating instructions for the safety belts, were sent to the accounts on 7/13/04.

Root cause

Other

Status

Terminated

Product code

FSA

Quantity affected

1,035 units

Distribution

Nationwide and Canada

Date initiated

2004-06-08

Date posted

2004-07-20

Date terminated

2004-12-13

Location

Roselle, IL