Recall Z-2143-2014 ยท IWZ Film, Radiographic
Carestream Health Inc.
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
| Date | Aug 1, 2014 (initiated Jul 2, 2014) |
| Status | Terminated |
| Reason | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees. |
| Root cause | Package design/selection |
| Action | Recall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031. |
| Quantity | 1633 boxes |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.