Drug recall
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System…
FDA recall event 69987 · Class II · Steris Corporation
Key facts
| Event ID | 69987 |
|---|---|
| Recall numbers | Z-0930-2015 |
| Recalling firm | Steris Corporation |
| Product type | Devices |
| Products | Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
| Initiation date | Nov 26, 2014 |
| Report date | Jan 14, 2015 |
| Termination date | Jul 11, 2015 |
| 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: