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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

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.
Recall Number Z-1404-2013
Classification Class II
Code Info Catalog Number 6937B002AA. All serial numbers from the first unit onward.
Product Distributed Qty 384 units
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.

Event Detail

Event Id 65082
Product Type Devices
Status Ongoing
Recalling Firm Canon Inc.
City Tokyo
Country JP
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.