Device recall
Z-0645-2013: ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
FDA device recall · Class II · Horiba Instruments, Inc dba Horiba Medical
Key facts
| Recall number (Z-number) | Z-0645-2013 |
|---|---|
| Recall event | 63829 |
| Product | ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 |
| Product code | JQP |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2013 |
| FEI number | 3002698356 |
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