Device recall
Z-1019-2010: RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1019-2010 |
|---|---|
| Recall event | 53541 |
| Product | RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.1. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples. |
| Product code | CHL |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2015 |
| 510(k) numbers | K002738 |
| FEI number | 3002637618 |
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