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Z-1404-2013 Class II Terminated

Recalled by Canon Inc. — Tokyo, N/A

Recall Details

Product Type: Devices
Report Date: June 5, 2013
Initiation Date: December 5, 2012
Termination Date: September 20, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 384 units

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.

Distribution Pattern

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.