Device recall
Z-2601-2016: Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software…
FDA device recall · Class III · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-2601-2016 |
|---|---|
| Recall event | 74564 |
| Product | Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in… |
| Product code | KHP |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 2, 2017 |
| 510(k) numbers | K113216 |
| FEI number | 3002637618 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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