Device recall
Z-0820-2015: CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-0820-2015 |
|---|---|
| Recall event | 69703 |
| Product | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. |
| Product code | LLZ |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2017 |
| 510(k) numbers | K020635, K923554 |
| FEI number | 1317307 |
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