Z-0141-2014Class II

Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment...

Name: Z-0141-2014 Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment...
Creator: Steris Corporation
Published: 2013-08-15
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-08-15 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital... on 2013-08-15. FDA classified it as Class II and gives the reason as "Drger 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0141-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-15
Posted: 2013-11-06
Terminated: 2014-04-28
Recalling firm: STERIS Corporation
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 for recall: Drger 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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Serial numbers 0422503114 - 0426604096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0141-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0141-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-06

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)