Events

Recall of FULL AUTO REF-KERATOMETER

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

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
    24583
  • Event Risk Class
    III
  • Event Initiated Date
    2013-01-14
  • 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
    Potential variations in values measured in the ref mode (refractive power) were reported with respect to the firmware included in rk-f2 full auto ref-keratometer. canon inc. has determined that there are potential variations in the optical system switching time between the alignment motor and measurement period and therefore fluctuations in measurement values may occur. canon inc. will resolve this potential issue by upgrading the firmware in the rk-f2 auto ref-keratometer.

Device

FULL AUTO REF-KERATOMETER
  • Model / Serial
    Model Catalog: RK-F2 (Lot serial: 200004); Model Catalog: RK-F2 (Lot serial: 200005); Model Catalog: RK-F2 (Lot serial: 200011)
  • Product Description
    Full Auto Ref-Keratometer
  • Manufacturer
    CANON CANADA INC.

Manufacturer

CANON CANADA INC.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC