Device recall
Z-1378-2015: CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or…
FDA device recall · Class II · Carestream Health, Inc.
Key facts
| Recall number (Z-number) | Z-1378-2015 |
|---|---|
| Recall event | 70649 |
| Product | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and… |
| Product code | MUH |
| Recalling firm | Carestream Health, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2017 |
| 510(k) numbers | K133406 |
| FEI number | 1317307 |
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