Device recall
Z-1391-2012: EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1391-2012 |
|---|---|
| Recall event | 61347 |
| Product | EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM)… |
| Product code | JJE |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2014 |
| FEI number | 2517506 |
At a glance
- None 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