Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Reported: August 13, 2014 Initiated: July 2, 2014 #Z-2143-2014
Product Description
Ultra-speed Dental Film, Catalog Number/REF 834 8658, 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.
Details
- Recalling Firm
- Carestream Health Inc.
- Units Affected
- 1633 boxes
- Distribution
- Worldwide Distribution.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.. Recalled by Carestream Health Inc.. Units affected: 1633 boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2014. Severity: Low. Recall number: Z-2143-2014.
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