Device recall
Z-2039-2016: CytoVision Image Analysis and Capture System, an automated cell-locating device…
FDA device recall · Class III · Leica Biosystems Richmond Inc.
Key facts
| Recall number (Z-number) | Z-2039-2016 |
|---|---|
| Recall event | 74245 |
| Product | CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a… |
| Product code | JOY |
| Recalling firm | Leica Biosystems Richmond Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 13, 2017 |
| 510(k) numbers | K042542 |
| FEI number | 1419341 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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