Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device ...
FDA Recall #Z-1404-2013 — Class II — December 5, 2012
Product Description
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.
Reason for Recall
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
Canon Inc. — Tokyo, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
384 units
Distribution
Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
Code Information
Catalog Number 6937B002AA. All serial numbers from the first unit onward.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated