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Recall Observatory FDA recall evidence

Device product

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

Z-2143-2014

July 02, 2014

Class III

Product summary

Firm
Carestream Health Inc.
Event
Event 68647
Status
Terminated
Classification
Class III
Quantity
1633 boxes
Official record key
device-enforcement:Z-2143-2014

Official wording

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.

Code information: Lot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.