Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0141-2014 — 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 equ

U.S. FDA — Device Enforcement · United States · 2013-08-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0141-2014
Date of alert
2013-08-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Steris Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0422503114
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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