Device recall
Z-0746-2017: Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0746-2017 |
|---|---|
| Recall event | 75385 |
| Product | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required |
| Product code | FTD |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2017 |
| FEI number | 1527821 |
At a glance
- None 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