Drug recall
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment…
FDA recall event 66138 · Class II · Steris Corporation
Key facts
| Event ID | 66138 |
|---|---|
| Recall numbers | Z-0141-2014 |
| Recalling firm | Steris Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 15, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Apr 28, 2014 |
| City | Mentor |
| State | OH |
| Country | United States |
| FEI number | 1527821 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: