Canon Inc.: Medical Device Recall in 2013 - (Recall #: Z-1404-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 5, 2012

Date Posted: June 5, 2013

Recall Number: Z-1404-2013

Event ID: 65082

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.

Status: Terminated

Product Quantity: 384 units

Code Information:

Catalog Number 6937B002AA. All serial numbers from the first unit onward.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated