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Recall Observatory FDA recall evidence

Device 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.

Z-0141-2014

August 15, 2013

Class II

Product summary

Firm
Steris Corporation
Event
Event 66138
Status
Terminated
Classification
Class II
Quantity
127 units
Official record key
device-enforcement:Z-0141-2014

Official wording

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

Code information: Serial numbers 0422503114 - 0426604096

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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