BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V

FDA device recall Z-1233-2008 · posted 2008-07-18 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.

Action taken

Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating the number of units requiring correction.

Root cause

Device Design

Status

Terminated

Product code

FNG

Quantity affected

25 units

Distribution

Nationwide Distribution.

Date initiated

2008-02-20

Date posted

2008-07-18

Date terminated

2010-09-11

Location

Roselle, IL