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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
Recall Number Z-0141-2014
Classification Class II
Code Info Serial numbers 0422503114 - 0426604096
Product Distributed Qty 127 units
Reason For Recall Dräger 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 system to lower unexpectedly.

Event Detail

Event Id 66138
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.