Reported Jun 5, 2013 · Terminated

Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to…

Canon Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Canon Inc. · 30-2, Shimomaruko 3-chome, · Tokyo, N/A · N/A

Is this the product you have?

    • Canon Full Auto Ref-Keratometer RK-F2
    • Catalog Number 6937B002AA
  • Product UsageThis device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye
Lot codes and dates
  • Catalog Number 6937B002AA. All serial numbers from the first unit onward.
Amount recalled
384 units

Where it was sold

  • Nationwide

Why it was recalled

Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 20, 2013 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.