Device recall
Z-1644-2008: EVMS (Enterprise Visual Medical System); Picture archiving and communications…
FDA device recall · Class III · Emageon
Key facts
| Recall number (Z-number) | Z-1644-2008 |
|---|---|
| Recall event | 47526 |
| Product | EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029. |
| Product code | LLZ |
| Recalling firm | Emageon |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 11, 2009 |
| 510(k) numbers | K053281 |
| FEI number | 1000116130 |
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