Z-1404-2013Class II

Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA

Name: Z-1404-2013 Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA
Creator: Canon Inc.
Published: 2012-12-05
License: https://open.fda.gov/license/

Canon Inc. / initiated 2012-12-05 / Terminated / root cause: software

FDA source

Canon Inc. began a recall of 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... on 2012-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1404-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-05
Posted: 2013-05-25
Terminated: 2013-09-20
Recalling firm: Canon Inc.
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.
Product code: HKO Refractometer, Ophthalmic
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 384 units
Distribution: Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
Product codes and lots: Catalog Number 6937B002AA. All serial numbers from the first unit onward.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1404-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-25

Product code HKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)