Recall Z-2142-2014— Carestream Health Inc.
Class III · Terminated
Class III FDA medical device recall by Carestream Health Inc., initiated 2014-07-02, terminated 2016-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.. 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..
- Recalling firm
- Carestream Health Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-07-02
- Terminated
- 2016-05-25
- Firm location
- Rochester, NY, United States
Product description
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.