Device recall
Z-1885-2016: Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-1885-2016 |
|---|---|
| Recall event | 73885 |
| Product | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting… |
| Product code | JJE |
| Recalling firm | Siemens Healthcare Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2017 |
| 510(k) numbers | K051087 |
| FEI number | 3002755490 |
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