Device recall
Z-1127-2014: Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579…
FDA device recall · Class II · Carestream Health Inc.
Key facts
| Recall number (Z-number) | Z-1127-2014 |
|---|---|
| Recall event | 67349 |
| Product | Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There… |
| Product code | EHD |
| Recalling firm | Carestream Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2015 |
| 510(k) numbers | K060292 |
| FEI number | 1315356 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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