Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101;

FDA device recall Z-1983-2011 · posted 2011-04-14 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

Reason for recall

The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.

Action taken

ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested 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

Device Design

Status

Terminated

Product code

FSA

Quantity affected

1,246 units

Distribution

Nationwide Distribution

Date initiated

2011-03-21

Date posted

2011-04-14

Date terminated

2012-02-16

Location

Addison, IL