Company: Canon Inc.
Date of Enforcement Report: 6/5/2013
Class ll:
PRODUCT
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. Recall Number Z-1404-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Canon Inc., Tokyo, Japan on 12/5/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
384 units
DISTRIBUTION
Nationwide and Internationally
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