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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH

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  Class 2 Device Recall Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH see related information
Date Initiated by Firm August 15, 2013
Date Posted November 06, 2013
Recall Status1 Terminated 3 on April 28, 2014
Recall Number Z-0141-2014
Recall Event ID 66138
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.
Code Information Serial numbers 0422503114 - 0426604096
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Lindsey M. McGowan
440-392-7519
Manufacturer 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
FDA Determined
Cause 2
Component design/selection
Action 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.
Quantity in Commerce 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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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