Device recall
Z-1388-2019: EDS Light Suspension, Central Axis, a component of the Stryker Visum LED…
FDA device recall · Class II · Stryker Communications
Key facts
| Recall number (Z-number) | Z-1388-2019 |
|---|---|
| Recall event | 82476 |
| Product | EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P… |
| Product code | FSY |
| Recalling firm | Stryker Communications |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K060802 |
| FEI number | 3002975342 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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