Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403

FDA device recall Z-0215-2008 · posted 2007-11-16 · Terminated

Recall details

Recalling firm

Skf USA Inc

Reason for recall

Sudden failure of the actuator during lifting operation

Action taken

On or about 7/24/07, the firm sent an Important Safety Information letter and instructions to all known OEMs who purchase and sell SKF actuators for use in patient lifts. The letter reiterated and emphasized the importance of proper handling and maintenance for the actuator. The firm enclosed with this correspondence a proposed letter that the OEMs were asked to send to their customers, including the safety instructions and a new warning label. The firm also is making available for OEMs, dealers and their customers new warning labels to place on all actuators in service. The root cause of the problem is still under investigation by the recalling firm and additional instruction may follow later

Root cause

Labeling design

Status

Terminated

Quantity affected

1,298 units (Z-0215-0217-2008)

Distribution

Worldwide Distribution-USA and Canada

Date initiated

2007-07-24

Date posted

2007-11-16

Date terminated

2013-04-26

Location

Norristown, PA