Device recall
Z-1141-2013: HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and…
FDA device recall · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-1141-2013 |
|---|---|
| Recall event | 64723 |
| Product | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. |
| Product code | JGS |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 26, 2014 |
| 510(k) numbers | K052007 |
| FEI number | 3002698356 |
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