Device recall
Z-2137-2014: KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and…
FDA device recall · Class II · Carestream Health Inc.
Key facts
| Recall number (Z-number) | Z-2137-2014 |
|---|---|
| Recall event | 68406 |
| Product | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator. |
| Product code | KPR |
| Recalling firm | Carestream Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2014 |
| FEI number | 1315356 |
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