Device recall
Z-1220-2010: Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-1220-2010 |
|---|---|
| Recall event | 54742 |
| Product | Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. 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 setting. |
| 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