Insight and Ultra-Speed (2014-07-02)

Starting date:

July 2, 2014

Posting date:

July 10, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40407

• Reason
• Affected products

Recalled Products

A) Insight
B) Ultra-Speed

Reason

Carestream has identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling of some lots of insight, item 811 0785 (size 0 packet), ib-01, and some lots of ultra-speed, item 834 8658 (size 0 packet), df-48. 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 film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees. The remaining content on the label is correct. Image quality is not affected by this issue.

Affected products