Device 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.
Z-1404-2013
Product summary
- Firm
- Canon Inc.
- Event
- Event 65082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 units
- Official record key
device-enforcement:Z-1404-2013
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.