Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Model

FDA device recall Z-1947-2012 · posted 2012-07-06 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

Reason for recall

ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.

Action taken

ArjoHuntleigh sent an "URGENT FIELD CORRECTION RECALL" notice dated June 25, 2012, to all affected customers via UPS Ground on June 29, 2012. The notice informed the accounts of the potential for severe patient injury if the proactive knee pad support is removed from the lift without the removal of the knee pad support bracket. The accounts were reminded that the entire knee pad and support bracket assembly must be removed from the lift when required to do so for exercise. An additional warning statement with diagrams was included in the notice. The accounts were requested to disseminate the information to all users of the affected lifts, to include a copy of the notice in the Instruction for Use Manuals for their lifts, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

FSA

Quantity affected

2,552 units in the U.S., 4,970 units in the rest of the world

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great B

Date initiated

2012-06-29

Date posted

2012-07-06

Date terminated

2018-03-13

Location

Addison, IL