Events

Recall of ULTRA-SPEED DENTAL INTRAORAL FILM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA COMPANY.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34797
  • Event Risk Class
    III
  • Event Initiated Date
    2014-06-26
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

ULTRA-SPEED DENTAL INTRAORAL FILM
  • Model / Serial
    Model Catalog: 834 8658 (Lot serial: 333-012-01); Model Catalog: 834 8658 (Lot serial: 333-012-02); Model Catalog: 834 8658 (Lot serial: 333-012-03); Model Catalog: 834 8658 (Lot serial: 343-015-01); Model Catalog: 811 0785 (Lot serial: 538-013-03); Model Catalog: 811 0785 (Lot serial: 539-012-01); Model Catalog: 811 0785 (Lot serial: 545-012-01); Model Catalog: 811 0785 (Lot serial: 546-012-01)
  • Product Description
    ULTRA-SPEED
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC