Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Syste

FDA device recall Z-0141-2014 · posted 2013-11-06 · Terminated

Recall details

Recalling firm

Steris Corporation

Reason for recall

Drger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS sys

Action taken

STERIS sent an Urgent Voluntary Field Correction Notice dated August 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS action- Drager Medical has provided STERIS instructions for inspection of the alignment of the mounting plate of the motor unit. If it is found that the mounting plate is bent, the drive screw within the motor unit must be replaced. STERIS will visit your facility to inspect the motorized ceiling supply unit of your Harmony EMS system(s) and if damage is observed, will replace the drive screw within the motor unit. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Root cause

Component design/selection

Status

Terminated

Quantity affected

127 units

Distribution

Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebras

Date initiated

2013-08-15

Date posted

2013-11-06

Date terminated

2014-04-28

Location

Mentor, OH