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Terminated

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.

FDA Recall Z-1404-2013 · Posted 2013-05-25

Recalling FirmCanon Inc.
Recall StatusTerminated
Product CodeHKO
Date Initiated2012-12-05
Date Terminated2013-09-20
Product Quantity384 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.

Firm Action

Canon initiated recall by sending letters on November 22, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken and contact information.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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