Device recall
Z-0418-2007: Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software…
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-0418-2007 |
|---|---|
| Recall event | 37083 |
| Product | Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system… |
| Product code | GKZ |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2012 |
| 510(k) numbers | K030828 |
| FEI number | 2050012 |
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