Recall Z-0141-2014— Steris Corporation

Class II FDA medical device recall by Steris Corporation, initiated 2013-08-15, terminated 2014-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Dr¿ger 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.

Recalling firm

Steris Corporation

Classification

Class II

Status

Terminated

Initiated

2013-08-15

Terminated

2014-04-28

Firm location

Mentor, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.