FDA-Device2014-08-13Class III
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Carestream Health Inc.
Hazard
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.
Sold states
Worldwide Distribution.
Affected count
1633 boxes
Manufactured in
150 Verona St, N/A, Rochester, NY, United States
Products
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2142-2014Don't want to check this manually?
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