Device recall
Z-1218-2010: Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-1218-2010 |
|---|---|
| Recall event | 54742 |
| Product | Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical… |
| Product code | FTD |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2012 |
| 510(k) numbers | K013242 |
| FEI number | 1527821 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database