PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 13, 2013 Initiated: August 15, 2013 #Z-0141-2014

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.

Reason for Recall

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

Details

Recalling Firm
Steris Corporation
Units 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, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Steris Corporation. Units affected: 127 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0141-2014.

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