Harmony Equipment Management System — Class II medical device recall Z-0141-2014
Terminated recall by Steris Corporation, reported 2013-11-13, distributed nationwide. Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motor
| Recall number | Z-0141-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2013-08-15 |
| Classified | 2013-11-06 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 127 units |
| Reason classes | device malfunction |
| Serial numbers | 0422503114, 0426604096 |
| Model numbers | 603X/80XX |
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
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.